Last updated: 11/02/2018 23:32:17
Long-Term Safety Of Ropinirole XR In Patients With Restless Legs Syndrome
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 52-Week, Open-Label Study to Assess the Long-Term Safety of Ropinirole Extended Release (XR) in Patients with Restless Legs Syndrome (RLS)
Trial description: The primary objective of this study is to assess the safety and tolerability of ropinirole XR in the long-term treatment (up to 52 weeks)of adults with RLS.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of participants with serious adverse events (AEs), non-serious adverse events, AEs leading to discontinuation of the study drug, and number of participants with AEs per severity
Timeframe: Up to 52 Weeks
Secondary outcomes:
Number of Participants With Change From Baseline in Systolic and Diastolic Blood Pressure of Potential Clinical Concern (PCC) Over 52 Weeks
Timeframe: Up to 52 Weeks
Number of participants with pulse rate of PCC at all on-treatment visits
Timeframe: Up to 52 Weeks
Change From Baseline in Body Weight Over 52 Weeks
Timeframe: Up to 52 Weeks
Number of participants with clinical laboratory evaluations of PCC at all visits
Timeframe: Up to 52 Weeks
Number of participants with abnormal electrocardiogram (ECG) finding at all on-treatment visits
Timeframe: Up to 52 Weeks
Number of participants with augmentation over 52 weeks
Timeframe: Up to 52 Weeks
Number of participants with early morning rebound (AE of special interest) over 52 weeks as a measure of worsening of RLS symptom
Timeframe: From Week 12 to Week 52
Change from Baseline in mean subjective total sleep time at each visit per RLS symptoms diary data over 52 weeks
Timeframe: Up to 52 Weeks
Mean subjective total sleep time at each visit per RLS symptoms diary data RLS symptom subgroup over 52 weeks
Timeframe: Up to 52 Weeks
Number of participants with difference in median time of onset of RLS symptoms between Baseline and each visit as per RLS symptoms diary data over 52 weeks
Timeframe: Baseline and up to 52 Weeks
Number of participants with modal parts of body affected by RLS symptoms at each visit as per RLS symptoms diary data over 52 weeks
Timeframe: Up to 52 Weeks
Percentage of participants with severity of RLS symptoms at each visit as per RLS symptoms diary data over 52 weeks
Timeframe: Baseline and up to Week 52
Percentage of participants with of RLS symptoms onset post sitting or resting at each visit as per RLS symptoms diary data over 52 weeks
Timeframe: From Baseline up to 52 Weeks
Mean Gambling symptoms assessment Scale (G-SAS) at Week 48 and 52
Timeframe: Week 48 and 52
Percentage of participants with response to hyper sexuality assessment questionnaire at 52 weeks
Timeframe: At 52 Weeks
Change from Baseline in the International RLS (IRLS) Rating Scale total score at Week 52 Last Observation Carried Forward (LOCF)
Timeframe: Baseline and up to 52 Weeks
Percentage of participants with a score of much improved (2) or very much improved (1) on the Clinical Global Impression Scale for Global Improvement (CGI-I) at Week 52 LOCF.
Timeframe: Week 52
Percentage of participants with CGI Severity of Illness (CGI-S) at Week 52 LOCF
Timeframe: Week 52
Change from Baseline (Day 0) in the domains of the Medical Outcomes Study (MOS-12) Sleep Scale at Week 52 LOCF
Timeframe: Baseline and Week 52
Change from Baseline (Day 0) in the overall life impact score of the RLS Quality of Life (QOL) Questionnaire at Week 52 LOCF
Timeframe: Baseline and Week 52
Change from baseline in the anxiety and depression domains of the Hospital Anxiety and Depression Scale (HADS) at Week 52 LOCF
Timeframe: Baseline and Week 52
Change from Baseline (Day 0) in the total score and domains of the Profile of Mood States (POMS) Scale Short Form at Week 52 LOCF
Timeframe: Baseline and Week 52
Change from Baseline (Day 0) in the parameters of the Work Productivity and Activity Impairment – Specific Health Problem (WPAI-SHP) Questionnaire at Week 52 LOCF
Timeframe: Baseline and Week 52
Percentage of participants satisfied with their treatment at Week 52 LOCF
Timeframe: Week 52
Interventions:
Drug: Ropinirole Extended Release (XR)
Enrollment:
386
Observational study model:
Not applicable
Primary completion date:
2007-04-10
Time perspective:
Not applicable
Clinical publications:
C Hill-Zabala, R Bogan, D Lee, M Lomax. A 52-week open-label study to assess the long-term tolerability of Ropinirole CR Extended Release Tablets in subjects with Restless Legs Syndrome (RLS). 12th International Congress of Parkinson’s Disease and Movement Disorders, Chicago, IL, June 22-26, 2008 (abstract 1112).
Medical condition
Restless Legs Syndrome
Product
ropinirole
Collaborators
Not applicable
Study date(s)
October 2005 to October 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Subjects in North America ≥18 years of age who
- Subjects who have any medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis.
- Subjects having clinically significant abnormal laboratory or ECG findings not resolved at time of baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias.
Inclusion and exclusion criteria
Inclusion criteria:
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Subjects in North America ≥18 years of age who a.Have successfully completed one of the following parent studies: 101468/205, ROX104805; OR b.Have a diagnosis of primary RLS using the International RLS Study Group (IRSSG) Diagnostic Criteria (Appendix 10), experience RLS symptoms during both the evening (before 8 PM) and night-time, and have a total score ≥15 on the IRLS Rating Scale at Baseline. Subjects must have a history of a minimum of 20 evenings/nights of RLS episodes per month (e.g., any combination of evenings and/or nights for ≥ 20 days). During Screening/Washout, RLS symptoms must be present for at least 4 of 7 evenings/nights immediately prior to the Baseline Visit (e.g., any combination of evenings and/or nights for ≥ 4 days).
- Subjects must give written informed consent prior to any specific study procedures.
Exclusion criteria:
- Subjects who have any medical conditions which, in the opinion of the investigator, could affect efficacy assessments or clinically significant or unstable medical conditions that present a safety concern. These may include, but are not limited to the following disorders: diabetes, peripheral neuropathy, rheumatoid arthritis, fibromyalgia syndrome, symptomatic orthostatic hypotension, severe cardiovascular disease, hepatic or renal failure, pleuro-pulmonary fibrosis.
- Subjects having clinically significant abnormal laboratory or ECG findings not resolved at time of baseline examinations. Abnormal 12-lead ECG findings include, but are not limited to the following: myocardial ischemia, clinically significant conduction abnormalities, or clinically significant arrhythmias.
- Subjects with a diastolic blood pressure ≥ 110mmHg or ≤ 50mmHg or systolic blood pressure ≥ 180mmHg or ≤ 90mmHg at the Screening or Baseline visit.
- Subjects with a history of augmentation and/or end-of-dose rebound symptoms. ·Augmentation is defined as RLS symptoms that occurred while on treatment and occur ≥ 2 hours earlier than they did before, symptoms which are more severe than when not treated, symptoms which start after less time at rest than they did before treatment, or symptoms which involve other parts of the body, such as the arms or trunk. ·End-of-dose rebound is defined as a re-emergence of RLS symptoms in the early morning the day after taking the dose of RLS medication.
- Subjects who have exhibited intolerance to ropinirole.
- For subjects entering Study 206, certain medications must be discontinued prior to entering the study. The following medications are prohibited for the duration of the study period which is up to and including the Follow-up visit: ·dopamine agonists (including ropinirole immediate release formulation), dopamine antagonists (e.g., typical neuroleptics, metoclopramide), levodopa/carbidopa The minimum discontinuation period is generally 5 half-lives or 7 consecutive evening/nights medication-free, prior to baseline, whichever is the longer period. If the subject will require longer than 2 weeks following the Follow-up visit of the parent study to complete the washout, GSK must be consulted for further instructions.
- Other medications, including those with partial dopaminergic activity (e.g., atypical antipsychotics, certain antidepressants such as bupropion, tricyclic antidepressants and monoamine oxidase inhibitors) may have additive activity with ropinirole and should be used with caution in patients taking ropinirole. For patients on stable doses, these agents may be permitted; however, it is recommended that the dose of the medication remain stable throughout the duration of the study.
- Night workers or any others whose sleeping habits are incompatible with the study design, or who would be required to make significant changes to their bedtime during the course of the study.
- Women who have a positive pregnancy test.
- Women of child-bearing potential who are not practicing a clinically accepted method of contraception such as oral contraception, surgical sterilization, IUD, diaphragm in conjunction with spermicidal foam and condom on the male partner, or systemic contraception (e.g. Norplant). The following exclusion criteria must be assessed at Study 206 Screen/Baseline for subjects who are not rolling in following completion of Study 101468/205 or ROX104805:
- Subjects who suffer from a primary sleep disorder other than RLS that may significantly affect the symptoms of RLS (e.g., narcolepsy, sleep terror disorder, sleepwalking disorder, breathing related sleep disorder).
- Subjects diagnosed with movement disorders (e.g., Parkinson's disease, dyskinesias, and dystonias).
- Signs of secondary RLS (e.g., end stage renal disease, iron deficient anemia or pregnancy at Baseline Visit)
- Subjects requiring treatment of daytime RLS symptoms (daytime defined as 7:00 AM until 5:00 PM).
- Subjects with a history of alcohol or substance abuse within the past year.
- Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule or other study procedures
- Participation in any clinical drug or device trial (other than Study 101468/205 or ROX104805) in the one month prior to the Baseline Visit
Trial location(s)
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Reseda, California, United States, 91355
Status
Study Complete
Location
GSK Investigational Site
Alabaster, Alabama, United States, 35007
Status
Study Complete
Location
GSK Investigational Site
Austell, Georgia, United States, 30106
Status
Study Complete
Location
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08003
Status
Study Complete
Location
GSK Investigational Site
Toms River, New Jersey, United States, 08755
Status
Study Complete
Location
GSK Investigational Site
Jackson, Tennessee, United States, 38305
Status
Study Complete
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33486
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Walla Walla, Washington, United States, 99362
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Laguna Hills, California, United States, 82653
Status
Study Complete
Location
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
Location
GSK Investigational Site
Medford, Oregon, United States, 97504-8456
Status
Study Complete
Location
GSK Investigational Site
Dawsonville, Georgia, United States, 30534
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
Mount Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01104
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Status
Study Complete
Location
GSK Investigational Site
Denver, Colorado, United States, 80212
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30338
Status
Study Complete
Location
GSK Investigational Site
Pasadena, California, United States, 91106
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85050
Status
Study Complete
Location
GSK Investigational Site
Schenectady, New York, United States, 12308
Status
Study Complete
Location
GSK Investigational Site
Greenville, North Carolina, United States, 27834
Status
Study Complete
Location
GSK Investigational Site
Oxnard, California, United States, 93030
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Endwell, New York, United States, 13760
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Georgia, United States, 30189
Status
Study Complete
Location
GSK Investigational Site
Redondo Beach, California, United States, 90277
Status
Study Complete
Location
GSK Investigational Site
Northridge, California, United States, 91325
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
Status
Study Complete
Location
GSK Investigational Site
Sun City, Arizona, United States, 85351
Status
Study Complete
Location
GSK Investigational Site
Alexandria, Virginia, United States, 22311
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22911
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-04-10
Actual study completion date
2007-04-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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