Parkinson DiseasePhase 3NCT00823836
Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease
A Phase 3 study testing ropinirole PR/XR and ropinirole IR in people with Parkinson Disease, run by GlaxoSmithKline at 54 sites in Japan.
Trial summary
To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa in a double-blind, parallel group comparison study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- ropinirole PR/XR and ropinirole IR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 54 sitesJapan
- Study dates
- Mar 2009to Dec 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with advanced Parkinson's disease (PD) with severity of the modified Hoehn \& Yahr criteria Stages II-IV.
- Subjects receiving a stable dose of L-dopa for at least 4 weeks prior to screening phase and demonstrating lack of control with L-dopa therapy in the following circumstances. Wearing-off phenomena. On-off fluctuations. Delayed-on/No on phenomena. Not adequately controlled on L-dopa
- QTc<450 millisecond (msec) or <480msec for patients with Bundle Branch Block - values based on either single ECG values or triplicate electrocardiogram (ECG) averaged QTc values obtained over a brief recording period.
- Age:20 years or older(at the time of informed written consent)
- Informed consent: Patients who are able to give informed written consent in person. (i.e. patients who are capable of giving informed written consent on one's own)
- Sex: either sex. Female of child-bearing potential will be eligible for inclusion in this study. However they have to have a negative pregnancy test at the screening visit, agree to further pregnancy testing at the time points determined in study assessments and procedures and practice one of the following methods of contraception from the screening visit until the end of the follow-up examination. Abstinence. Injectable progestogen. Implants of levonorgestrel. Estrogenic vaginal ring. Percutaneous contraceptive patches. Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. Double barrier method: condom or occlusive cap (diaphragm or cervical / vault caps) plus spermicidal agent (foam /gel / film / cream / suppository)
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- Both inpatient and outpatient status.
- Inclusion Criteria at the start of the non-inferiority verification phase
- -Patients whose Unified Parkinson's Disease Rating Scale (UPDRS) PartIII total (on) scores is 10 points or more at week 0.
Who cannot join
- Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinesia on their stable dose of L-dopa.
- Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992).
- Patients with symptomatic postural hypotension. (e.g. dizziness and syncope).
- Patients with a current or history of drug abuse or alcoholism.
- Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation).
- Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study or within 30 days after the last dose of the study drug.
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- Patients with chronic hepatitis typeB and/or type C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody.
- Patients with a history of drug allergy to ropinirole hydrochloride (HCl).
- Patients with a current or history of cancer or malignant tumor.
- Others whom the investigator (subinvestigator) considers ineligible for the study.
- Exclusion criteria at the start of the non-inferiority verification phase
- Patients with severe dementia (e.g. score 3 or 4 of the UPDRS item 1 (Intellectual Impairment))
- Patients with current or history of major psychosis (e.g. schizophrenia or psychotic depression) core 3 or 4 of the UPDRS item 2 (thought disorder) or item 3(depression).
- Patients who have used any dopamine agonist within 4 weeks prior to the non-inferiority verification phase
- Patients who have been treated with the following drugs at 4 weeks or earlier before the start of the non-inferiority verification phase, and whose treatment regimen of the drug has been changed. Anticholinergic agents: trihexyphenidyl hydrochloride (e.g. Artane®), piroheptine hydrochloride (Trimol®), mazaticol hydrochloride (Pentona®), metixene hydrochloride (Cholinfall®), biperiden hydrochloride (Akineton®), profenamine (Parkin®), amantadine hydrochloride (e.g. Symmetrel®),droxidopa (Dops®), citicoline (e.g. Nicholin®), selegiline hydrochloride (FP®), entacapone, (comutan®) zonisamide, Estrogens: e.g. estriol (e.g. Estriel®), CYP1A2 inhibitors: Ciprofloxacin HCl (e.g. Ciproxan®, enoxacin and fluvoxamine).
- Patients who have been treated with any other investigational drug within 12 weeks prior to the treatment phase.
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Japan54 sites
GSK Investigational Site
Aichi, 454-0933
GSK Investigational Site
Aichi, 460-0008
GSK Investigational Site
Aichi, 465-8620
GSK Investigational Site
Aichi, 489-8642
GSK Investigational Site
Akita, 010-0874
GSK Investigational Site
Chiba, 260-8712
GSK Investigational Site
Chiba, 270-1337
GSK Investigational Site
Chiba, 270-2251
GSK Investigational Site
Chiba, 279-0021
GSK Investigational Site
Chiba, 290-0003
GSK Investigational Site
Ehime, 791-0295
GSK Investigational Site
Fukuoka, 800-0296
GSK Investigational Site
Fukuoka, 814-0180
GSK Investigational Site
Fukuoka, 816-0864
GSK Investigational Site
Fukuoka, 819-8585
GSK Investigational Site
Fukushima, 963-8052
GSK Investigational Site
Hokkaido, 068-0027
GSK Investigational Site
Hyōgo, 651-2273
GSK Investigational Site
Hyōgo, 670-0981
GSK Investigational Site
Hyōgo, 674-0081
GSK Investigational Site
Ibaraki, 310-0011
GSK Investigational Site
Kanagawa, 232-0066
GSK Investigational Site
Kanagawa, 247-8533
GSK Investigational Site
Kanagawa, 251-0038
GSK Investigational Site
Kanagawa, 252-0392
GSK Investigational Site
Kanagawa, 253-8558
GSK Investigational Site
Kyoto, 600-8811
GSK Investigational Site
Kyoto, 601-1495
GSK Investigational Site
Kyoto, 610-0113
GSK Investigational Site
Kyoto, 616-8255
GSK Investigational Site
Miyagi, 983-8520
GSK Investigational Site
Nagano, 399-0157
GSK Investigational Site
Nagano, 399-8695
GSK Investigational Site
Nagasaki, 859-3615
GSK Investigational Site
Nara, 632-8552
GSK Investigational Site
Okayama, 703-8265
GSK Investigational Site
Osaka, 530-8480
GSK Investigational Site
Osaka, 543-8555
GSK Investigational Site
Osaka, 560-8552
GSK Investigational Site
Osaka, 570-8507
GSK Investigational Site
Osaka, 578-8588
GSK Investigational Site
Osaka, 590-0132
GSK Investigational Site
Osaka, 596-8522
GSK Investigational Site
Osaka, 598-0048
GSK Investigational Site
Saitama, 343-0032
GSK Investigational Site
Saitama, 359-1141
GSK Investigational Site
Shiga, 524-0022
GSK Investigational Site
Shizuoka, 416-0955
GSK Investigational Site
Shizuoka, 420-8688
GSK Investigational Site
Tochigi, 329-0498
GSK Investigational Site
Tokyo, 113-8431
GSK Investigational Site
Tokyo, 136-0075
GSK Investigational Site
Tokyo, 183-8524
GSK Investigational Site
Tokyo, 202-0004
About this study
Official title: Clinical Evaluation of Ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease
To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa in a double-blind, parallel group comparison study.
- Conditions
- Parkinson Disease
- Being tested
- ropinirole PR/XR, ropinirole IR
- Keywords
- Ropinirole, advanced Parkinson's disease, L-dopa adjunctive therapy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropinirole PR/XRDrug
Also called ropinirole IR-PR group
Double-blind non-inferiority verification phase (24 weeks) At the baseline visit (Week 0), subjects who completed screening period will be randomised (1:1) to double-blind treatment with either ropinirole PR-PR group or ropinirole IR-PR group.
The subjects'dose will be titrated according to the recommended schedule to achieve an optimal therapeutic response (ropinirolePR/XR2-15 mg/day ,ropinirolIR0.75-15 mg/day).
Double-blind PR/XR switching phase (8 weeks) Ropinirole IR-PR subjects will be switched overnight to a similar dose of ropinirole PR/XR, while the remaining ropinirole PR-PR group will continue on the same dosage.
Double blind long-term treatment phase (22 weeks) The same dose level at the end of PR/XR switching phase will be continued till week 54 under blind.
Down titration phase Subjects who complete Week 54 or withdrawn will be down titrated over a 1 to 4 weeks period.
ropinirole IRDrug
Double-blind non-inferiority verification phase (24 weeks) At the baseline visit (Week 0), subjects who completed screening period will be randomised (1:1) to double-blind treatment with either ropinirole PR-PR group or ropinirole IR-PR group.
The subjects'dose will be titrated according to the recommended schedule to achieve an optimal therapeutic response (ropinirolePR/XR2-15 mg/day ,ropinirolIR0.75-15 mg/day).
Double-blind PR/XR switching phase (8 weeks) Ropinirole IR-PR subjects will be switched overnight to a similar dose of ropinirole PR/XR, while the remaining ropinirole PR-PR group will continue on the same dosage.
Double blind long-term treatment phase (22 weeks) The same dose level at the end of PR/XR switching phase will be continued till week 54 under blind.
Down titration phase Subjects who complete Week 54 or withdrawn will be down titrated over a 1 to 4 weeks period.
| Study group | Role | What they receive |
|---|---|---|
| ropinirolePR-PR group | Experimental | Not described Receives: Drug: ropinirole PR/XR |
| ropiniroleIR-PR group | Active comparator | Not described Receives: Drug: ropinirole PR/XR; Drug: ropinirole IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase
The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants who withdrew before Week 2 and who had only one observation for the part III total score were not included in the analysis.
Measured: Week 0 and FAP (up to Week 24)
Secondary outcomes (61)
Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score. On-treatment last observations within the phase were carried forward as FAP values of the phase. FAP values do not include values of Weeks 0, 1, and 2; participants who withdrew before Week 2 and who had only one measurement for the part III total score were not included in the analysis.
Measured: FAP (up to Week 24)
Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.
Measured: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in the Japanese UPDRS Part II (at "On") Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the score at Week 0.
Measured: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in the Japanese UPDRS Part II (at "Off") Total Score at Week 24 in the Non-Inferiority Verification Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Particpants with only one observation for the part II (at "Off") total score were not included in the analysis.
Measured: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0.
Measured: Week 0 and FAP (up to Week 24)
Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Measured: Week 0 and FAP (up to Week 24)
Japanese UPDRS Part II (at "On") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is defined as the state at which PD symptoms are well controlled by the drug.
Measured: Week 0 and FAP (up to Week 24)
Japanese UPDRS Part II (at "Off") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug.
Measured: Week 0 and FAP (up to Week 24)
Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Measured: Week 0 and FAP (up to Week 24)
Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Measured: Week 0 and FAP (up to Week 24)
Percentage of Responders on the Clinical Global Impression-Improvement (CGI-I) at FAP (up to Week 24) in the Non-Inferiority Verification Phase
The CGI-I assesses the participant's improvement or worsening of PD from Baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.
Measured: FAP (up to Week 24)
Percentage of Responders in Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on change from Week 0 in Off time (percentage).
Measured: FAP (up to Week 24)
Percentage of Responders in Percent Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in percent change from Week 0 in Off time (percentage).
Measured: FAP (up to Week 24)
Mean Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 0.
Measured: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in Percentage of Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "Off" time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 0.
Measured: Week 0 and FAP (up to Week 24)
Mean Percent Change From Week 0 in Percentage of Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "Off" time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Percent change from Week 0 in Off time (proportion) is measured using the following formula: (Change from Week 0 in Off time [proportion]/Off time [proportion] at Week 0) x 100.
Measured: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in Awake Time Spent "On" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Mean Change from Week 0 in On time (actual hours) was calculated as On time (hours) at FAP minus On time (hours) at Week 0. Participants who had only one observation for On time were not included in the analysis.
Measured: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in Percentage of Awake Time Spent "On" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
"On" state is defined as the state at which PD symptoms are well controlled by the drug. "On" time is measured as a proportion using the following formula: (Sum of two days On time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in On time is measured using the following formula: On time (proportion) at FAP minus On time (proportion) at Week 0. Participants who had only one observation for On time were not included in the analysis.
Measured: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in Awake Time Spent "On" With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis.
Measured: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in Percentage of Awake Time Spent "On" With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase
"On" time with troublesome dyskinesias is measured as a proportion using the following formula: (Sum of two days On time with troublesome dyskinesias [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in On time with troublesome dyskinesias is measured using the following formula: On time with troublesome dyskinesias (proportion) at FAP minus On time with troublesome dyskinesias (proportion) at Week 0. Participants who had only one observation for On time with troublesome dyskinesias were not included in the analysis.
Measured: Week 0 and FAP (up to Week 24)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase
The Modified Hoehn \& Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. "On" state is defined as the state at which PD symptoms are well controlled by the drug.
Measured: Week 0 and FAP (up to Week 24)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase
The Modified Hoehn \& Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug.
Measured: Week 0 and FAP (up to Week 24)
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group
The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.
Measured: 0-175 days (up to Week 24)
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group
The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 24) was the event, and participants who had completed the phase were censored.
Measured: 0-175 days (up to Week 24)
Mean Change From Week 24 (Period Baseline) in the Japanese UPDRS Part I Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in the Japanese UPDRS Part II (at "On") Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in the Japanese UPDRS Part II (at "Off") Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "Off" state is where PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in the Japanese UPDRS Part III Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in the Japanese UPDRS Part IV Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 24 was calculated as the total score at FAP minus the total score at Week 24.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Japanese UPDRS Part I Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Japanese UPDRS Part II (at "On") Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is defined as the state at which PD symptoms are well controlled by the drug.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Japanese UPDRS Part II (at "Off") Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had "off" state were included in the analysis.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Japanese UPDRS Part III Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Japanese UPDRS Part IV Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. One participant whose observation could not be obtained at Week 24 was not included in the analysis for Week 24.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in Awake Time Spent "Off" at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 24 in Off time (actual hours) was calculated as Off time (hours) at FAP minus Off time (hours) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in Percentage of Awake Time Spent "Off" at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "Off" time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 24 in Off time is measured using the following formula: Off time (proportion) at FAP minus Off time (proportion) at Week 24. Participants whose observation could not be obtained after Week 24 because of their premature withdrawal or other reasons were not included in the analysis.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in Awake Time Spent "On" With Troublesome Dyskinesias at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 24 on On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at FAP minus On time with troublesome dyskinesias (hours) at Week 24. Participants who had 0 hour as On time with troublesome dyskinesias at Week 24 were excluded from the analysis.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Modified Hoehn \& Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. "On" state is defined as the state at which PD symptoms are well controlled by the drug.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
The Modified Hoehn \& Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Only participants who had "off" state were included in the analysis.
Measured: Week 24 and FAP (from Week 26 up to Week 32)
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group
The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.
Measured: 0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole IR-Ropinirole PR Group
The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 32) was the event, and participants who had completed the phase were censored.
Measured: 0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)
Percentage of Responders on the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
Thirty percent responders were defined as participants with a 30 percent or greater reduction from Week 0 (Baseline) in the Japanese UPDRS Part III total score. Twenty percent responders were defined as participants with a 20 percent or greater reduction from Week 0 in the Japanese UPDRS Part III total score.
Measured: Week 54
Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.
Measured: Weeks 0 and 54
Mean Change From Week 0 in the Japanese UPDRS Part II (at "On") Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is defined as the state at which PD symptoms are well controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.
Measured: Weeks 0 and 54
Mean Change From Week 0 in the Japanese UPDRS Part II (at "Off") Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.
Measured: Weeks 0 and 54
Mean Change From Week 0 in the Japanese UPDRS Part III Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.
Measured: Weeks 0 and 54
Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications. Mean change from Week 0 was calculated as the total score at Week 54 minus the total score at Week 0.
Measured: Weeks 0 and 54
Japanese UPDRS Part I Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Japanese UPDRS assesses the status of PD patients objectively. Part I assesses mentation, behavior, and mood on 4 items. Participants receive a score of 0-4 points per item. The maximum total score is 16 points. A higher score indicates more severe mental symptoms.
Measured: Weeks 0 and 54
Japanese UPDRS Part II (at "On") Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "On" state is defined as the state at which PD symptoms are well controlled by the drug.
Measured: Weeks 0 and 54
Japanese UPDRS Part II (at "Off") Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Japanese UPDRS assesses the status of PD patients objectively. Part II assesses activities of daily living on 13 items. Participants receive a score of 0-4 points per item. The maximum total score is 52 points. A higher score indicates more severe PD symptoms. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug.
Measured: Weeks 0 and 54
Japanese UPDRS Part III Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Japanese UPDRS assesses the status of PD patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms.
Measured: Weeks 0 and 54
Japanese UPDRS Part IV Total Score at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Japanese UPDRS assesses the status of PD patients objectively. Part IV assesses complications of therapy on 11 items. Participants receive a score of 0-4 or 0-1 points per item depending on the item. The maximum total score is 23 points. A higher score indicates more severe symptoms of complications.
Measured: Weeks 0 and 54
Percentage of Responders on the CGI-I at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The CGI-I assesses the participant's improvement or worsening of PD from baseline with the following eight grades: 0 = Not Assessed, 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. Responders are defined as those participants with scores of very much improved or much improved.
Measured: Week 54
Percentage of Responders in Change From Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction in change from Week 0 in Off time (percentage).
Measured: Week 54
Percentage of Responders in Percent Change From Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Responders were defined as participants with a 20 percent or greater reduction on percent change from Week 0 in Off time (percentage).
Measured: Week 54
Mean Change From Week 0 in Awake Time Spent "Off" at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. Mean change from Week 0 in Off time (actual hours) was calculated as Off time (hours) at Week 54 minus Off time (hours) at Week 0.
Measured: Weeks 0 and 54
Mean Change From Week 0 in Percentage of Awake Time Spent "Off" at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
"Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug. "Off" time is measured as a proportion using the following formula: (Sum of two days off time [hours]/Sum of two days awake time [hours]) x 100. Change from Week 0 in Off time is measured using the following formula: Off time (proportion) at Week 54 minus Off time (proportion) at Week 0.
Measured: Weeks 0 and 54
Mean Change From Week 0 in Awake Time Spent "On" With Troublesome Dyskinesias at Week 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
"On" state is defined as the state at which PD symptoms are well controlled by the drug. Troublesome dyskinesia is defined as dyskinesia that interferes with the participant's daily activity. Mean change from Week 0 in On time with troublesome dyskinesias (actual hours) was calculated as On time with troublesome dyskinesias (hours) at Week 54 minus On time with troublesome dyskinesias (hours) at Week 0.
Measured: Weeks 0 and 54
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Modified Hoehn \& Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. "On" state is defined as the state at which PD symptoms are well controlled by the drug.
Measured: Weeks 0 and 54
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Weeks 0 and 54 in the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The Modified Hoehn \& Yahr criteria are measured on the following 8-point scale for disease severity: 0, No signs of disease; 1, Unilateral disease; 1.5, Unilateral plus axial involvement; 2, Bilateral disease; 2.5, Mild bilateral disease; 3, Mild to moderate bilateral disease; 4, Severe disability; and 5, Wheelchair bound or bedridden unless aided. "Off" state is defined as the state at which PD symptoms are not adequately controlled by the drug.
Measured: Weeks 0 and 54
Percentage of Participants Remaining in the Study on the Indicated Days During the Long-term Phase in the Ropinirole PR-Ropinirole PR Group
The percentage of participants remaining in the study was presented by Kaplan-Meier method, where premature discontinuation (i.e., withdrawal before Week 54) was the event, and participants who had completed the study were censored.
Measured: 0-385 days (up to Week 54)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00823836
- Sponsor's protocol ID
- 106066
- Status last verified
- Nov 2016
- First submitted
- 15 Jan 2009
- Last updated
- 18 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00823836
- Acronym / sponsor ID
- 106066
- Conditions
- Parkinson Disease
- Keywords
- Ropinirole, advanced Parkinson's disease, L-dopa adjunctive therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Posted 7 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy and the safety of ropinirole PR/XR tablets to ropinirole immediate release (IR) tablets with advanced Parkinson's disease in conjunction with L-dopa in a double-blind, parallel group comparison study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ropinirolePR-PR group | Experimental | Drug: ropinirole PR/XR |
| ropiniroleIR-PR group | Active comparator | Drug: ropinirole PR/XR, Drug: ropinirole IR |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who are diagnosed with advanced Parkinson's disease (PD) with severity of the modified Hoehn \& Yahr criteria Stages II-IV.
- Subjects receiving a stable dose of L-dopa for at least 4 weeks prior to screening phase and demonstrating lack of control with L-dopa therapy in the following circumstances. Wearing-off phenomena. On-off fluctuations. Delayed-on/No on phenomena. Not adequately controlled on L-dopa
- QTc<450 millisecond (msec) or <480msec for patients with Bundle Branch Block - values based on either single ECG values or triplicate electrocardiogram (ECG) averaged QTc values obtained over a brief recording period.
- Age:20 years or older(at the time of informed written consent)
- Informed consent: Patients who are able to give informed written consent in person. (i.e. patients who are capable of giving informed written consent on one's own)
Key exclusion criteria (16 listed)
- Late stage advanced subjects demonstrating incapacitating peak dose or biphasic dyskinesia on their stable dose of L-dopa.
- Patients who present serious physical signs and symptoms other than those of the PD (e.g. cardiac/hepatic/renal disorder and haematopoietic disorder). The severity refers to Grade 3 according to "the Classification of the Severity of Adverse Experiences (Pharmaceutical affairs bureau/Safety division (PAB/SD) Notification No. 80, dated 29 June 1992).
- Patients with symptomatic postural hypotension. (e.g. dizziness and syncope).
- Patients with a current or history of drug abuse or alcoholism.
- Patients who have received surgical treatment for PD in the past (e.g. pallidectomy, deep brain stimulation).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropinirole PR/XRAlso: ropinirole IR-PR groupDouble-blind non-inferiority verification phase (24 weeks) At the baseline visit (Week 0), subjects who completed screening period will be randomised (1:1) to double-blind treatment with either ropinirole PR-PR group or ropinirole IR-PR group. The subjects'dose will be titrated according to the recommended schedule to achieve an optimal therapeutic response (ropinirolePR/XR2-15 mg/day ,ropinirolIR0.75-15 mg/day). Double-blind PR/XR switching phase (8 weeks) Ropinirole IR-PR subjects will be switched overnight to a similar dose of ropinirole PR/XR, while the remaining ropinirole PR-PR group will continue on the same dosage. Double blind long-term treatment phase (22 weeks) The same dose level at the end of PR/XR switching phase will be continued till week 54 under blind. Down titration phase Subjects who complete Week 54 or withdrawn will be down titrated over a 1 to 4 weeks period. | Drug | ropiniroleIR-PR group, ropinirolePR-PR group |
| ropinirole IRDouble-blind non-inferiority verification phase (24 weeks) At the baseline visit (Week 0), subjects who completed screening period will be randomised (1:1) to double-blind treatment with either ropinirole PR-PR group or ropinirole IR-PR group. The subjects'dose will be titrated according to the recommended schedule to achieve an optimal therapeutic response (ropinirolePR/XR2-15 mg/day ,ropinirolIR0.75-15 mg/day). Double-blind PR/XR switching phase (8 weeks) Ropinirole IR-PR subjects will be switched overnight to a similar dose of ropinirole PR/XR, while the remaining ropinirole PR-PR group will continue on the same dosage. Double blind long-term treatment phase (22 weeks) The same dose level at the end of PR/XR switching phase will be continued till week 54 under blind. Down titration phase Subjects who complete Week 54 or withdrawn will be down titrated over a 1 to 4 weeks period. | Drug | ropiniroleIR-PR group |
Primary outcome
Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
The Japanese UPDRS assesses the status of Parkinson's Disease (PD) patients objectively. Part III assesses motor examination on 27 items. Participants receive a score of 0-4 points per item. The maximum total score is 108 points. A higher score indicates more severe PD symptoms. Mean change from Week 0 was calculated as the total score at FAP minus the total score at Week 0. Participants who withdrew before Week 2 and who had only one observation for the part III total score were not included in the analysis.
61 secondary outcomes
Percentage of Responders on the Japanese UPDRS Part III Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: FAP (up to Week 24)
Mean Change From Week 0 in the Japanese UPDRS Part I Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in the Japanese UPDRS Part II (at "On") Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in the Japanese UPDRS Part II (at "Off") Total Score at Week 24 in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in the Japanese UPDRS Part IV Total Score at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Japanese UPDRS Part I Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Japanese UPDRS Part II (at "On") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Japanese UPDRS Part II (at "Off") Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Japanese UPDRS Part III Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Japanese UPDRS Part IV Total Score at Week 0 and FAP (up to Week 24) in the Non-inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Percentage of Responders on the Clinical Global Impression-Improvement (CGI-I) at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: FAP (up to Week 24)
Percentage of Responders in Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: FAP (up to Week 24)
Percentage of Responders in Percent Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: FAP (up to Week 24)
Mean Change From Week 0 in Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in Percentage of Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Mean Percent Change From Week 0 in Percentage of Awake Time Spent "Off" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in Awake Time Spent "On" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in Percentage of Awake Time Spent "On" at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in Awake Time Spent "On" With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Mean Change From Week 0 in Percentage of Awake Time Spent "On" With Troublesome Dyskinesias at FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 0 and FAP (up to Week 24) in the Non-Inferiority Verification Phase
Time frame: Week 0 and FAP (up to Week 24)
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole PR-Ropinirole PR Group
Time frame: 0-175 days (up to Week 24)
Percentage of Participants Remaining in the Study on the Indicated Days During the Non-Inferiority Verification Phase in the Ropinirole IR-Ropinirole PR Group
Time frame: 0-175 days (up to Week 24)
Mean Change From Week 24 (Period Baseline) in the Japanese UPDRS Part I Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in the Japanese UPDRS Part II (at "On") Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in the Japanese UPDRS Part II (at "Off") Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in the Japanese UPDRS Part III Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in the Japanese UPDRS Part IV Total Score at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Japanese UPDRS Part I Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Japanese UPDRS Part II (at "On") Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Japanese UPDRS Part II (at "Off") Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Japanese UPDRS Part III Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Japanese UPDRS Part IV Total Score at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in Awake Time Spent "Off" at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in Percentage of Awake Time Spent "Off" at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Mean Change From Week 24 in Awake Time Spent "On" With Troublesome Dyskinesias at FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "On") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Number of Participants at Each Stage of the Modified Hoehn & Yahr Severity of Illness (at "Off") at Week 24 and FAP (From Week 26 up to Week 32) in the PR/XR Switching Phase
Time frame: Week 24 and FAP (from Week 26 up to Week 32)
Percentage of Participants Remaining in the Study on the Indicated Days During the PR/XR Switching Phase in the Ropinirole PR-Ropinirole PR Group
Time frame: 0-89 days within the PR/XR Switching Phase (between Weeks 24 and 32)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ropinirole PR/XR and ropinirole IR in people with Parkinson Disease, run by GlaxoSmithKline at 54 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Week 0 (Baseline) in the Japanese Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score at the Final Assessment Point (FAP) (up to Week 24) in the Non-Inferiority Verification Phase (time frame: Week 0 and FAP (up to Week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2017.