Parkinson's DiseasePhase 3NCT00593606
Safety and Tolerability Trial of Switching From Ropinirole to Rotigotine
A Phase 3 study testing Rotigotine in people with Parkinson's Disease, run by UCB Pharma.
Trial summary
This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of switching from ropinirole therapy to the rotigotine transdermal system and its effect on symptoms in subjects with idiopathic Parkinson's disease Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Rotigotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Dec 2007
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is informed and given ample time and opportunity to think about his/her participation in this trial and has given his/her written informed consent.
- Subject is willing and able to comply with all trial requirements.
- Subject is male or female, aged≥ 18 years.
- Subject is Korean.
- Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV) as defined by the cardinal sign, bradykinesia, and at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes.
- Subject is not satisfactorily controlled on a total daily dose of ropinirole from 3mg to 12mg, inclusive.
- If the subject is receiving levodopa, either short-acting or sustained-release (in combination with benserazide or carbidopa), the total daily dose must be stable for 28 days prior to the Baseline Visit and must remain stable for the Treatment Period.
- If the subject is receiving an anticholinergic agent (eg, benztropine, trihexyphenidyl, parsitan, procyclidine, biperiden), a monoamine oxidase B (MAO-B) inhibitor (eg, selegiline), a COMT inhibitor (eg, entacapone), or an N-methyl-d-aspartate (NMDA)-antagonist (eg, amantadine), he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the Treatment Period
Who cannot join
- Subjects are not permitted to enroll in the trial if any of the following criteria are met:
- Subject has previously participated in a trial with rotigotine.
- Subject has participated in another trial of an investigational drug within 28 days prior to the Baseline Visit or is currently participating in another trial of an investigational drug.
- Subject has atypical Parkinsonian syndrome(s), including drug-induced Parkinsonian syndrome(s).
- Subject has dementia, active psychosis, or hallucinations (not due to antiparkinsonian medication).
- Subject is receiving therapy with 1 of the following drugs either concurrently or within 28 days prior to Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, quetiapine), monoamine oxidase A (MAO-A) inhibitors, methylphenidate, or amphetamine.
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- Subject is currently receiving central nervous system (CNS) active therapy (eg, sedatives, hypnotics, antidepressants, anxiolytics), unless the dose has been stable for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the trial.
- Subject has a history of seizures or stroke within 1 year, has had a Transient Ischemic Attack (TIA) within 12 months prior to enrollment, or a history of myocardial infarction within the last 6 months prior to enrollment.
- Presence of clinically relevant hepatic dysfunction.
- Presence of clinically relevant renal dysfunction.
- Evidence of clinically relevant cardiovascular disorders.
- Subject has a QTcB interval of ≥ 500ms at Pretreatment or Baseline (repeated measurements within 1 hour).
- Subject has a history of symptomatic (not asymptomatic) orthostatic hypotension in the 6 months prior to Baseline.
- Subject has a history of significant skin hypersensitivity to adhesive or other transdermals or recent unresolved contact dermatitis.
- Subject has malignant neoplastic disease requiring therapy within 12 months prior to enrollment.
- Subject has a history of chronic alcohol or drug abuse within the last 6 months.
- Subject has taken herbal medicine therapy within the last 2 weeks prior to the Baseline Visit.
- Subject has clinically significant laboratory results that, in the judgment of the investigator, would make the subject unsuitable for entry into the trial.
- Subject is pregnant or nursing, or is of childbearing potential but (i) not surgically sterile or (ii) not using adequate birth control methods (including at least 1 barrier method), or (iii) not sexually abstinent or (iv) not at least 2 years postmenopausal.
- Subject has evidence of an impulse control disorder according to the Jay Modified Minnesota Impulsive Disorders Interview (mMIDI) at Pretreatment (Visit 1).
- Subject has any other clinically significant medical or psychiatric condition that would, in the judgment of the investigator, interfere with the subject's ability to participate in this trial.
About this study
Official title: A Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's Disease
This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of switching from ropinirole therapy to the rotigotine transdermal system and its effect on symptoms in subjects with idiopathic Parkinson's disease
- Conditions
- Parkinson's Disease
- Being tested
- Rotigotine
- Keywords
- Rotigotine, NEUPRO, Switching trial from ropinirole to rotigotine,, safety and tolerability, Parkinson disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotigotineDrug
Also called Neupro
Strength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application
| Study group | Role | What they receive |
|---|---|---|
| Rotigotine | Experimental | Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking. Receives: Drug: Rotigotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pulse Rate (Supine, After 1 Minute)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Systolic Blood Pressure (Supine, After 1 Minute)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Diastolic Blood Pressure (Supine, After 1 Minute)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Pulse Rate (Supine, After 5 Minutes)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Systolic Blood Pressure (Supine, After 5 Minutes)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 Days
Change in Diastolic Blood Pressure (Supine, After 5 Minutes)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Pulse Rate (Standing, After 1 Minute)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Systolic Blood Pressure (Standing, After 1 Minute)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Diastolic Blood Pressure (Standing, After 1 Minute)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Pulse Rate (Standing, After 3 Minutes)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Systolic Blood Pressure (Standing, After 3 Minutes)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Diastolic Blood Pressure (Standing, After 3 Minutes)
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Heart Rate
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in PR Interval
The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex).
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in QRS Duration
The QRS duration represents the time it takes for ventricular depolarization to occur.
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in QT Interval
The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)
The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization.
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Percentage of Basophilic Granulocytes in White Blood Cell Count
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Hematocrit
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Hemoglobin
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Percentage of Lymphocytes in White Blood Cell Count
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Percentage of Monocytes in White Blood Cell Count
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Platelet Count
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Red Blood Cell Count
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in White Blood Cell Count
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Albumin
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Alkaline Phosphatase
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Blood Urea Nitrogen
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Calcium
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Chloride
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Creatinine
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Gamma-Glutamyltransferase
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Glucose
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Inorganic Phosphate
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Potassium
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Serum Glutamic Oxaloacetic Transaminase
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Glutamic Pyruvic Transaminase
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Sodium
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Total Bilirubin
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Total Protein
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Uric Acid
Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'
Measured: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'
Measured: 28 days
Completion of Trial From Baseline to End of Treatment
Measured: Baseline, 28 days
Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment
Measured: Baseline, 28 days
Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Measured: Baseline, 2 days
Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Measured: Baseline, 56 days
Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Measured: Baseline, 2 days
Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Measured: Baseline, 56 days
Secondary outcomes (22)
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment
The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part I measures 'Mentation, Behavior and Mood'. Range: 0 (Best score possible) to 16 (Worst score possible) Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment
The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part II measures 'Activities in Daily Living'. Range: 0 (Best score possible) to 52 (Worst score possible) Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment
The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part III measures 'Motor Examination'. Range: 0 (Best score possible) to 56 (Worst score possible) Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment
The UPDRS is a scale for the assessment of function in Parkinson's disease UPDRS Part IV measures 'Complications of Therapy'. Range: 0 (Best score possible) to 23 (Worst score possible) Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment
The PDSS is a scale to assess sleep and nocturnal disability in Parkinson's disease.
Range: 0 (Best score possible) to 60 (Worst score possible) Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment
The ESS is a self-administered questionnaire in which the subject rates the probability of his/her dozing during 8 situations that are differently conductive to sleep Range: 0 (Best score possible) to 24 (Worst score possible) Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment
The PDNMS is a rating by the clinician to assess the severity and frequency of non-motor symptoms in Parkinson's disease patients Range: 0 (Best score possible) to 384 (Worst score possible) Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment
The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 1 measures 'Severity of Parkinson's Disease'. Range: 1 (Normal, not ill at all) to 7 (Among the most extremely ill patients) Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Clinical Global Impression (CGI) Item 2 Score
The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 2 measures 'Global Improvement'. Range 1 (Very much improved) to 7 (Very much worse)
Measured: 28 days
Clinical Global Impression (CGI) Item 3.1
The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 3.1 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms.) to 4 (Unchanged or worse)
Measured: 28 days
Clinical Global Impression (CGI) Item 3.2
The CGI is a set of ratings made by a clinician in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 3.2 measures 'Therapeutic Side Effects'. Range: 1 (None) to 4 (Outweigh the therapeutic effect)
Measured: 28 days
Patient Global Impression (PGI) Item 1 Score
The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 1 measures 'Global Improvement'. Range: 1 (Very much improved) to 7 (Very much worse)
Measured: 28 days
Patient Global Impression (PGI) Item 2
The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 2 measures 'Therapeutic Effect'. Range: 1 (Marked - Vast improvement. Complete or nearly complete remission of all symptoms) to 4 (Unchanged or worse)
Measured: 28 days
Patient Global Impression (PGI) Item 3
The PGI is a set of ratings made by the patient in order to assess the overall severity of an individual's symptoms as well as changes in his/her functioning over time.
Item 3 measures 'Side Effects'. Range: 1 (I have no side effects) to 4 (They outweigh the therapeutic effect of the trial medication)
Measured: 28 days
Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment
The PDQ-8 is a self-administered 8-item questionnaire that assesses issues associated with Parkinson's disease.
Range: 0 (good health) to 100 (poor health) Change = 28 day value minus baseline value.
Measured: Baseline, 28 days
Patient Treatment Preference Scale Question 1
Have you used pharmaceutical treatments for your Parkinson's disease before the study?
Measured: 28 days
Patient Treatment Preference Scale Question 2
Why did you decide to enter this study?
Measured: 28 days
Patient Treatment Preference Scale Question 3
In comparing the patch and previous oral treatments for Parkinson's disease, how satisfied have you been with oral medication / patch?
Measured: 28 days
Patient Treatment Preference Scale Question 4
I would prefer using a patch over taking a pill or capsule for treatment of my Parkinson's disease.
Measured: 28 days
Patient Treatment Preference Scale Question 5
I would prefer applying one 40cm2 patch over applying two 20cm2 patches for treatment of my Parkinson's disease.
Measured: 28 days
Patient Treatment Preference Scale Question 6
What aspects do you like the most about the patch?
Measured: 28 days
Patient Treatment Preference Scale Question 7
What aspects do you like the least about the patch? Check all that apply.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2007
- Study completionDec 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593606
- Sponsor's protocol ID
- SP0908
- Status last verified
- Oct 2011
- First submitted
- 21 Dec 2007
- Last updated
- 2 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Kim HJ, Jeon BS, Lee WY, Lee MC, Kim JW, Kim JM, Ahn TB, Cho J, Chung SJ, Grieger F, Whitesides J, Boroojerdi B. Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease. BMC Neurol. 2011 Aug 10;11:100. doi: 10.1186/1471-2377-11-100.
PubMed 21831297
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00593606
- Acronym / sponsor ID
- SP0908
- Conditions
- Parkinson's Disease
- Keywords
- Rotigotine, NEUPRO, Switching trial from ropinirole to rotigotine,, safety and tolerability, Parkinson disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Posted 27 May 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 3b, open-label, multicenter trial to assess the safety and tolerability of switching from ropinirole therapy to the rotigotine transdermal system and its effect on symptoms in subjects with idiopathic Parkinson's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotigotine | Experimental | Drug: RotigotinePatients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is informed and given ample time and opportunity to think about his/her participation in this trial and has given his/her written informed consent.
- Subject is willing and able to comply with all trial requirements.
- Subject is male or female, aged≥ 18 years.
- Subject is Korean.
- Subjects with idiopathic Parkinson's disease (Hoehn and Yahr Stage I-IV) as defined by the cardinal sign, bradykinesia, and at least 1 of the following: resting tremor, rigidity, or impairment of postural reflexes.
Key exclusion criteria (21 listed)
- Subjects are not permitted to enroll in the trial if any of the following criteria are met:
- Subject has previously participated in a trial with rotigotine.
- Subject has participated in another trial of an investigational drug within 28 days prior to the Baseline Visit or is currently participating in another trial of an investigational drug.
- Subject has atypical Parkinsonian syndrome(s), including drug-induced Parkinsonian syndrome(s).
- Subject has dementia, active psychosis, or hallucinations (not due to antiparkinsonian medication).
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 |
|---|---|---|
| RotigotineAlso: NeuproStrength: 2,4,6,and 8mg/24h, form: transdermal application, once daily application | Drug | Rotigotine |
Primary outcome
Change in Pulse Rate (Supine, After 1 Minute)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Supine, After 1 Minute)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Supine, After 1 Minute)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Supine, After 5 Minutes)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Supine, After 5 Minutes)
Time frame: Baseline, 28 Days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Supine, After 5 Minutes)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Standing, After 1 Minute)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Standing, After 1 Minute)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Standing, After 1 Minute)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Pulse Rate (Standing, After 3 Minutes)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Systolic Blood Pressure (Standing, After 3 Minutes)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Diastolic Blood Pressure (Standing, After 3 Minutes)
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Heart Rate
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in PR Interval
Time frame: Baseline, 28 days
The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization (beginning of the QRS complex). Change = 28 day value minus baseline value.
Change in QRS Duration
Time frame: Baseline, 28 days
The QRS duration represents the time it takes for ventricular depolarization to occur. Change = 28 day value minus baseline value.
Change in QT Interval
Time frame: Baseline, 28 days
The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. Change = 28 day value minus baseline value.
Change in QT Interval Corrected for Heart Rate According to Bazett's Formula (QTcB)
Time frame: Baseline, 28 days
The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. Change = 28 day value minus baseline value.
Change in Percentage of Basophilic Granulocytes in White Blood Cell Count
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Percentage of Eosinophilic Granulocytes in White Blood Cell Count
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Hematocrit
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Hemoglobin
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Percentage of Lymphocytes in White Blood Cell Count
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Percentage of Monocytes in White Blood Cell Count
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Percentage of Neutrophilic Granulocytes Segmented in White Blood Cell Count
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Platelet Count
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Red Blood Cell Count
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in White Blood Cell Count
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Albumin
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Alkaline Phosphatase
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Blood Urea Nitrogen
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Calcium
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Chloride
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Creatinine
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Gamma-Glutamyltransferase
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Glucose
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Inorganic Phosphate
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Potassium
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Serum Glutamic Oxaloacetic Transaminase
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Glutamic Pyruvic Transaminase
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Sodium
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Total Bilirubin
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Total Protein
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Change in Uric Acid
Time frame: Baseline, 28 days
Change = 28 day value minus baseline value.
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Ears, Eyes, Nose, Mouth, Throat'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Psychiatric'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hematological/Lymphatic Nodes'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Dermatological'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Cardiovascular'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Peripheral Vascular'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Pulmonary'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Musculoskeletal'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Hepato-/Gastrointestinal'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Renal/Genitourological'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Metabolic/Endocrine'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Physical Examination for 'Other'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Mental Status'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Deep Tendon Reflexes'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Muscle Strength'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Cranial Nerve Function'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Plantar Reflex'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Gait'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Coordination/Balance'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Involuntary Movements'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Sensory Perception'
Time frame: 28 days
Occurrence of Abnormal, Clinically Relevant Events in Neurological Examination for 'Other'
Time frame: 28 days
Completion of Trial From Baseline to End of Treatment
Time frame: Baseline, 28 days
Completion of Trial on the Original Treatment Assignment From Baseline to End of Treatment
Time frame: Baseline, 28 days
Drop-out During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Time frame: Baseline, 2 days
Drop-out Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Time frame: Baseline, 56 days
Dose Reduction During the 5 Half-life Overlap Period Due to Adverse Events (AEs)
Time frame: Baseline, 2 days
Dose Reduction Due to Adverse Events (AEs) With Onset During the 5 Half-life Overlap Period
Time frame: Baseline, 56 days
22 secondary outcomes
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score From Baseline to End of Treatment
Time frame: Baseline, 28 days
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score From Baseline to End of Treatment
Time frame: Baseline, 28 days
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score From Baseline to End of Treatment
Time frame: Baseline, 28 days
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score From Baseline to End of Treatment
Time frame: Baseline, 28 days
Change in Parkinson's Disease Sleep Scale (PDSS) Sum Score From Baseline to End of Treatment
Time frame: Baseline, 28 days
Change in Epworth Sleepiness Scale (ESS) Sum Score From Baseline to End of Treatment
Time frame: Baseline, 28 days
Change in Parkinson's Disease Non-Motor Symptom Assessment Scale (PDNMS) Total Sum Score From Baseline to End of Treatment
Time frame: Baseline, 28 days
Change in Clinical Global Impression (CGI) Item 1 Score From Baseline to End of Treatment
Time frame: Baseline, 28 days
Clinical Global Impression (CGI) Item 2 Score
Time frame: 28 days
Clinical Global Impression (CGI) Item 3.1
Time frame: 28 days
Clinical Global Impression (CGI) Item 3.2
Time frame: 28 days
Patient Global Impression (PGI) Item 1 Score
Time frame: 28 days
Patient Global Impression (PGI) Item 2
Time frame: 28 days
Patient Global Impression (PGI) Item 3
Time frame: 28 days
Change in Short-form Parkinson's Disease Questionnaire (PDQ-8) Single Index Score From Baseline to End of Treatment
Time frame: Baseline, 28 days
Patient Treatment Preference Scale Question 1
Time frame: 28 days
Patient Treatment Preference Scale Question 2
Time frame: 28 days
Patient Treatment Preference Scale Question 3
Time frame: 28 days
Patient Treatment Preference Scale Question 4
Time frame: 28 days
Patient Treatment Preference Scale Question 5
Time frame: 28 days
Patient Treatment Preference Scale Question 6
Time frame: 28 days
Patient Treatment Preference Scale Question 7
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21831297Kim HJ, Jeon BS, Lee WY, Lee MC, Kim JW, Kim JM, Ahn TB, Cho J, Chung SJ, Grieger F, Whitesides J, Boroojerdi B. Overnight switch from ropinirole to transdermal rotigotine patch in patients with Parkinson disease. BMC Neurol. 2011 Aug 10;11:100. doi: 10.1186/1471-2377-11-100.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Product InformationLink provided by the sponsor.
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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.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rotigotine in people with Parkinson's Disease, run by UCB Pharma.
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 8 inclusion and 21 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 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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 27 May 2009). 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?
Change in Pulse Rate (Supine, After 1 Minute) (time frame: Baseline, 28 days). The study lists 71 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00593606, which also lists 1 linked publication.
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 2 Oct 2014.