AzTrials
AzTrials

Restless Legs SyndromePhase 2NCT00530790

Clinical Evaluation of Ropinirole CR-RLS ( SK&F101468)Tablets in Restless Legs Syndrome

A Phase 2 study of Restless Legs Syndrome, run by GlaxoSmithKline at 11 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
Restless Legs Syndrome
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
11 sitesJapan
Study dates
23 Aug 2007to 1 Feb 2008
Phase
Phase 2
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 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
  • At Week -1 (at the start of Screening period)
  • Patients who are diagnosed with RLS according to the International RLS Study Group's (IRLSSG) Diagnostic Criteria.
  • Age: Patients aged at least 18 years and under 80 years.
  • Patients who have had RLS symptoms in the evening or nighttime (17:00 to 7:00 next day) for at least 20 days within one month before the start of the screening period. Patients treated for RLS before the start of the Screening period and who do not meet this criterion are considered eligible if the previous therapy can be discontinued from the Screening period.
  • Patients who experience RLS symptoms requiring treatment after 17:00 but prior to bedtime.
Show all 22Show fewer
  • Gender: male and female Female of child-bearing potential will be eligible for inclusion in this study. However they must have a negative pregnancy test at the Screening visit. They agree are perform pregnancy test at the time determined and practice one of the following method of contraception from the Screening visit till the end of follow-up examination.
  • Abstinence
  • Oral Contraceptive, either combined or progestogen alone
  • 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
  • Inpatient or outpatient status: Outpatient status
  • Patients who are able to give informed written consent in person. For patients aged under 20 years, their legally acceptable representatives are able to give informed written consent.
  • At Week 0 (at the start of treatment period)
  • Patients who experience RLS symptoms in the evening and nighttime (17:00 to 7:00 next day) for at least 4 days within 7 days before the start of the treatment period.
  • Patients who have sleep impairment associated with RLS. Patients who answered as 3 (severe) or 4 (very severe) to Question 4 (Sleep disturbance) in the IRLS Rating Scale
  • Patients whose IRLS Rating Scale total scores are 15 points or more.

Who cannot join

  • Patients requiring treatment for daytime RLS symptoms (7:00 to 17:00).
  • Patients with signs of secondary RLS (e.g. chronic renal failure, iron-deficiency anemia, pregnancy, rheumatoid arthritis and Parkinson's disease).
  • Patients whose serum ferritin level is <10 μg/L (ng/mL) at the start of Screening period.
  • Patients with following sleep disorder not associated with RLS e.g. narcolepsy, sleep terror disorder, sleep walking disorder, breathing related sleep disorder (Patients with obvious apnea in nighttime sleeping when they do not have alcohol drinking or over 15 times/hour is used to a target for apnea hypopnea index,in which case to implement polysomnography), etc.
  • Patients with complication of movement disorder (e.g. Parkinson's disease, dyskinesia, dystonia, etc.).
  • Patients with severe hepatic/renal/cardiac/pulmonary disorder or hematopoietic disorder.
Show all 22Show fewer
  • 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 the medical history or complication of cancer or malignant tumour.
  • Patients with the medical history or complication of substance abuse (e.g. alcohol or drug) or dependency of substance for the last one year
  • Patients whose diastolic blood pressure (BP) is >110 mmHg or <50 mmHg or whose systolic BP is >180 mmHg or <90 mmHg at the start of Screening period and Week0.
  • Patients intolerant for ropinirole hydrochloride (HCl) or other dopamine agonists.
  • Patients with the medical history of allergy to ropinirole HCl in the past.
  • Patients with the medical history of Augmentation to ropinirole HCl or other dopamine agonists in the past and those who have experienced early morning RLS symptoms.
  • Augmentation is defined as below:
  • RLS appear 2 hours earlier than the pre-treatment. Symptoms become severer than the pre-treatment. Symptoms which start after less time at rest than they did before treatment. The RLS extend to other sites (e.g. arm and trunk).
  • Patients without nighttime sleeping habit (e.g. night-shift worker, etc.) and those who must drastically change the habitual bedtime during the study duration.
  • Patients who have participated in another clinical study of an investigational product or medical device within the last 12 weeks prior to the start of screening period.
  • Female patients who are pregnant or lactating, who may be pregnant, or who plan for pregnancy during the study .
  • Patients with chronic hepatitis typeB and /or typeC which is positive of hepatitis B surface antigen （HBsAg）and/or hepatitis C antibody.
  • Patients who have medical conditions which, in the opinion of investigator could affect efficacy and safety assessment. This may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, fibromyalgia syndrome, symptomatic orthostatic hypotension, hepatic or renal failure, pleuro-pulmonary fibrosis.
  • Patients who have received treatment of an estrogen drug product and a drug that are known to substantially inhibit CYP1A2 and have changed the dose from baseline visit to Week 0.
  • Others whom the investigator (sub investigator) considers ineligible for the study.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Japan11 sites

  • GSK Investigational Site

    Fukuoka, 802-0084

  • GSK Investigational Site

    Fukuoka, 810-0044

  • GSK Investigational Site

    Fukuoka, 830-0011

  • GSK Investigational Site

    Hiroshima, 733-0031

  • GSK Investigational Site

    Kanagawa, 210-0024

  • GSK Investigational Site

    Osaka, 550-0004

  • GSK Investigational Site

    Osaka, 589-0022

  • GSK Investigational Site

    Osaka, 599-8263

  • GSK Investigational Site

    Tochigi, 321-0293

  • GSK Investigational Site

    Tokyo, 151-0053

  • GSK Investigational Site

    Tokyo, 187-0041

Other trials in Japan

About this study

Official title: Clinical Evaluation of Ropinirole CR-RLS Tablets in Restless Legs Syndrome-Open-Label, Uncontrolled Study. Classification: Clinical Pharmacology, Exploratory

This study was designed to evaluate the safety, pharmacokinetic profile and efficacy in Restless Legs Syndrome patients.

Being tested
ropinirole controlled release (CR)-RLS
Keywords
Restless Legs Syndrome
Medical subject headings
Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ropinirole controlled release (CR)-RLSDrug

    Also called Ropinirole CR-RLS (SK&F101468)

    White film-coated round-shaped tablet

Study groups in NCT00530790
Study groupRoleWhat they receive
ropinirole CR-RLSExperimentalSubjects will orally take ropinirole CR-RLS tablet(s) once daily 1-2 hours before the onset of RLS symptoms at about the same time of the day. The time of taking ropinirole must be after 16:00.Adjustment of the Ropinirole CR-RLS tablets should be completed after the Week 1 visit up to the Week 10 visit. The dose will be increased at intervals of at least one week until sufficient efficacy is obtained (use "much improved" as a guide) without safety problem. Dose escalation will start at the initial dose 0.5 mg/day to 1 mg/day; after 1 mg/day, the dose will be increased by 1 mg/day to the maximum 6 mg/day.
Receives: Drug: ropinirole controlled release (CR)-RLS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Drug Related Adverse Events-On-Therapy

    Measured: Weeks 1 - 12 Treatment Period

  2. Haematology Clinical Lab Values Change From Baseline

    Standard units of measure vary. Therefore, Mean Change is represented in Standard Units: Hematocrit = SI unit of GSK; Hemoglobin = G/L; Platelet count, White Blood Cell count = GI/L; Red Blood Cell count = TI/L. n = number of subjects evaluated. EW = Early Withdrawal.

    Measured: Baseline - Week 13 (Follow-up)

  3. Blood Chemistry Clinical Lab Values Change From Baseline

    Mean Change in Standard Units of Measure: Albumin, Total Protein=G/L; Alkaline Phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase, Lactate Dehydrogenase, Creatine Phosphokinase, Gamma Glutamyl Transferase=IU/L; Total Bilirubin, Creatinine=UMOL/L; Blood Urea Nitrogen, Cholesterol, Chloride, Sodium, Potassium=MMOL/L; Prolactin=MCG/L

    Measured: Baseline - Week 13 (Follow-up)

  4. Urinalysis Clinical Lab Values

    Dipstick test values: Neg Value, Trace, +1, +2, +3. No subjects tested higher than +3.

    Measured: Baseline - Week 13 (Follow-up)

  5. 12-Lead Electrocardiogram (ECG) Findings Transitions From Baseline

    Baseline Finding/Time Period Finding. Abbreviations: N = normal; A = abnormal; CS = clinically significant; NCS = not clinically significant. Options include N/N, N/ANCS, N/ACS, ANCS/N, ANCS/ANCS, ANCS/ACS, ACS/N, ACS/ANCS, and ACS/ACS.

    Measured: Baseline, Week 4, 8, 12, 13 (Follow-up)

  6. Vital Signs and Body Weight Change From Baseline

    Units of Measure Vary: Weight = kg; Semi-supine and Standing Systolic and Diastolic BP = mmHg; Semi-supine and Standing Pulse Rate = bpm; EW = early withdrawal; Semi-supine = lying down; Orthostatic = lying, sitting, and standing.

    Measured: Baseline to Week 12/EW

Secondary outcomes (11)

  1. Change From Baseline to Week 12 in International Restless Leg Syndrome (IRLS) Rating Scale Total Score

    The IRLS Scale assesses the severity of sensory and motor symptoms, sleep disturbance, daytime somnolence, and impact on activities of daily living and mood. The questionnaire scores various questions and totals them using the following scale: Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points.

    Measured: Baseline and after Week 12

  2. Clinical Global Impression Scale - Severity of Illness (CGI-S)

    The CGI-S scale measures the overall severity of illness on a 7 point scale. Normal = 1, Borderline = 2, Mildly = 3, Moderately = 4, Markedly = 5, Severely = 6, Extremely Severe = 7(no subjects scored a 7).

    Measured: Baseline - Final assessment point

  3. Clinical Global Impression Global Improvement (CGI-GI)

    CGI-GI is a 7 point scale assessing Global Improvement. 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse (no patients scored a 5, 6, or 7).

    Measured: Baseline - Final assessment point

  4. Change From Baseline at Week 12/Early Withdrawal (EW) in Pittsburgh Sleep Quality Index (PSQI) Total Score

    The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.

    Measured: Baseline - Week 12/EW

  5. Change From Baseline to Week 12/EW in Pittsburgh Sleep Quality Index (PSQI) Total Score by Domains

    The PSQI generates seven scores that correspond to different domains. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The domain scores are totaled to produce a global score (range of 0-21). A PSQI global score > 5 is considered to be suggestive of significant sleep disturbance.

    Measured: Baseline - Week 12/EW

  6. Change From Baseline at Week 12/Early Withdrawal (EW) in Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire (RLSQOL) on the Overall Life Impact Score

    The RLSQOL scale consists of 18 items, 13 of which are scored on a 5-point scale. Ten of the items can be summed to the overall life impact score, which can be transformed to a 0-100 score. Mild = 84.48, Moderate = 62.93, or Severe = 37.47

    Measured: Baseline and Week 12/EW

  7. Change From Baseline at Week 12/Early Withdrawal (EW) in Profile of Mood Status (POMS)

    The POMS Standard form contains 65 items (0-232). The respondent rates each item on a 5-point scale, ranging from "Not at all (0)" to "Extremely (4)." The assessment measures six identified mood factors:

    • Tension-Anxiety
    • Depression-Dejection
    • Anger-Hostility
    • Vigor-Activity
    • Fatigue-Inertia
    • Confusion-Bewilderment

    Measured: Baseline and Week 12/EW

  8. Change From Baseline at Week 12/Early Withdrawal (EW) in Hospital Anxiety and Depression Scale (HADS)

    Self screening questionnaire that requires the first response to questions. Questionnaire consists of 14 questions, seven for anxiety "0-21" and seven for depression "0-21". Questions are answered on a four point scale from 0-3; Items 1, 3, 5, 6, 8, 10, 11, and 13 are reversed for summation.

    Measured: Baseline - Week 12/EW

  9. Pharmacokinetic Analysis: Plasma Concentrations of SK&F101468, an Unchanged Form of Ropinirole.

    Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&101468 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.

    Measured: Weeks 1-12

  10. Pharmacokinetic Analysis: Plasma Concentrations of SK&F104557, a Circulating Metabolite of Ropinirole.

    Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&104557 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.

    Measured: Weeks 1 -12

  11. Pharmacokinetic Analysis: Plasma Concentrations of SK&F89124, a Circulating Metabolite of Ropinirole.

    Plasma samples taken at 24 hours after dosing had been administered for 3 days or longer. This was repeated if the dose was escalated. Lower Limits of Quantitation (LLQ) for SK\&89124 = 20 pg/mL. The lowest concentration of analyte can be measured with established acceptable accuracy and precision.

    Measured: Weeks 1-12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2007 (estimated)
  2. Study start23 Aug 2007
  3. Primary completion1 Feb 2008
  4. Study completion1 Feb 2008

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00530790
Sponsor's protocol ID
107846
Status last verified
Aug 2018
First submitted
14 Sep 2007
Last updated
26 Sep 2018
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.

Publications

  • GSK has concluded that it is not feasible to publish this study in a peer-reviewed scientific journal because the nature of the study is unlikely to be of interest to a journal. GSK is providing the attached study results summary with a conclusion.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study of Restless Legs Syndrome, run by GlaxoSmithKline at 11 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 22 inclusion and 22 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 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 24 Jul 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?

Drug Related Adverse Events-On-Therapy (time frame: Weeks 1 - 12 Treatment Period). The study lists 6 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 NCT00530790, 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 26 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in