Last updated: 11/04/2018 10:31:31
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome(CR-RLS)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients with Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep
Trial description: The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Mean change from Baseline to Week 12 Last observations carried forward (LOCF) in periodic limb movement index (PLMI)
Timeframe: Baseline (Day 0) and Week 12
Secondary outcomes:
Number of participants with <=5 PLMI/hour sleep
Timeframe: Week 12
Mean changes from Baseline to Week 12 (LOCF) in periodic limb movements during waking per hour of wake (PLMWI)
Timeframe: Baseline (Day 0) and Week 12
Change from Baseline in periodic limb movements in sleep associated with arousal/hr sleep (PLMAI)
Timeframe: Baseline (Day 0) and Week 12
Mean changes from Baseline to Week 12 (LOCF) in total sleep time (TST)
Timeframe: Baseline (Day 0) and Week 12
Mean changes from Baseline to Week 12 LOCF in sleep efficiency
Timeframe: Baseline (Day 0) and Week 12
Mean changes from Baseline to Week 12 LOCF in Sleep Onset Latency (SOL)
Timeframe: Baseline (Day 0) and Week 12
Mean changes from Baseline to Week 12 LOCF in Latency to Persistent Sleep (LPS)
Timeframe: Baseline (Day 0) and Week 12
Mean changes from Baseline to Week 12 LOCF in Number of awakenings Measured by PSG
Timeframe: Baseline (Day 0) and Week 12
Mean changes from Baseline to Week 12 LOCF in Wake time during sleep (WTDS) Measured by PSG
Timeframe: Baseline (Day 0) and Week 12
Mean changes from Baseline to Week 12 LOCF in Wake time after sleep onset (WASO)
Timeframe: Baseline (Day 0) and Week 12
Number of participants who report that the medication “Helped me get a better night’s sleep, helped me sleep, helped me sleep longer and helped me fall asleep faster at Week 12 (LOCF)
Timeframe: Week 12
Change from Baseline to Week 12 LOCF in TST assessed by post-sleep questionnaire
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in sleep latency assessed by Post-Sleep Questionnaire
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in, sleep quality assessed by Post-Sleep Questionnaire
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in number of awakenings assessed by Post-Sleep Questionnaire
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in sleep depth assessed by Post-Sleep Questionnaire
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in sleepiness assessed by Post-Sleep Questionnaire
Timeframe: Baseline (Day 0) and Week 12
Number of participant’s response of Alert or Very Alert to “How clear headed did you feel after getting up this morning? And Fairly Satisfied or Completely Satisfied to “How satisfied were you with last nights sleep?”
Timeframe: Up to Week 12
Mean change from baseline to Week 12 (LOCF) in subjective sleep Latency assessed by Post-Sleep Diary
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in daytime alertness assessed by subjective pre-sleep questionnaire
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in ability to function assessed by subjective pre-sleep questionnaire
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in sense of wellbeing assessed by Subjective Pre-Sleep Questionnaire
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in sleep adequacy domain of the Medical Outcomes Study (MOS) Sleep Scale
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in sleep disturbance domain of MOS Sleep Scale
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in sleep quantity domain of MOS Sleep Scale
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline to Week 12 (LOCF) in day time somnolence domains of MOS Sleep Scale
Timeframe: Baseline (Day 0) and Week 12
Mean change from baseline to Week 12 (LOCF) in the International restless leg rating scale (IRLS) total score assessed by IRLS
Timeframe: Baseline (Day 0) and Week 12
Mean change from baseline to Week 12 (LOCF) in Item 4 (sleep disturbance) score assessed by IRLS
Timeframe: Baseline (Day 0) and Week 12
Number of participants with response to Clinical global impression improvement of illness scale (CGI-I) rating of 1 or 2 at Week 12 (LOCF)
Timeframe: Week 12
Number of participants with adverse events (AEs) and serious adverse events (SAEs) and intensity of AEs
Timeframe: Up to 15 weeks
Summary of Changes in sitting blood pressure (BP) at screening and up to Week 12
Timeframe: Up o Week 12
Summary of Changes in pulse up to Week 12
Timeframe: Up to Week 12
Summary of orthostatic change in systolic and diastolic BP at Day 0 and PSG visits
Timeframe: Day 0 (Pre-Dose, 2 hours (Hrs) Post-Dose, 4 hrs Post-Dose) and Week 12
Summary of orthostatic change in pulse at Day 0 and PSG visits
Timeframe: Day 0 (Pre-Dose, 2 hrs Post-Dose, 4 hrs Post-Dose) and Week 12
Number of participants with ambulatory systolic and diastolic BP values outside potential clinical concern (PCC)
Timeframe: Up to Week 12
Summary of changes in ambulatory systolic and diastolic BP
Timeframe: Baseline (Day 0) up to Week 12
Number of participants with change in laboratory values of PCC (Hematology and chemistry)
Timeframe: Up to Week 12
Interventions:
Enrollment:
39
Primary completion date:
2007-21-06
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Restless Legs Syndrome (RLS)
Product
ropinirole
Collaborators
Not applicable
Study date(s)
October 2006 to June 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 79 years
Accepts healthy volunteers
No
- provided written informed consent.
- Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
- Secondary RLS
- Primary sleep disorder
Inclusion and exclusion criteria
Inclusion criteria:
- provided written informed consent.
- Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.
- Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.
- Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.
Exclusion criteria:
- Secondary RLS
- Primary sleep disorder
- Have any medical conditions that may impact efficacy assessments or that may present a safety concern.
- Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.
- Use of any prohibited medication.
Trial location(s)
Location
GSK Investigational Site
Greenwood, Colorado, United States, 80111
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40217
Status
Study Complete
Location
GSK Investigational Site
Elk Grove Village, Illinois, United States, 60007
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Auburn, Maine, United States, 04210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greenville, North Carolina, United States, 27835
Status
Study Complete
Location
GSK Investigational Site
Lafayette Hill, Pennsylvania, United States, 19444
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97219
Status
Study Complete
Location
GSK Investigational Site
Corvallis, Oregon, United States, 97330
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44195
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Crestview Hills, Kentucky, United States, 41017
Status
Study Complete
Location
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Status
Study Complete
Location
GSK Investigational Site
Danville, Indiana, United States, 46122
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33707
Status
Study Complete
Location
GSK Investigational Site
Brandon, Florida, United States, 33511
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45246
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33026
Status
Study Complete
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Lafayette, Louisiana, United States, 70503
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63143
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Austell, Georgia, United States, 30106
Status
Study Complete
Location
GSK Investigational Site
Toms River, New Jersey, United States, 08755
Status
Study Complete
Location
GSK Investigational Site
Brighton, Massachusetts, United States, 02135
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85006
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97239
Status
Study Complete
Location
GSK Investigational Site
Normal, Illinois, United States, 61761
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92108
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Walla Walla, Washington, United States, 99362
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Status
Study Complete
Location
GSK Investigational Site
Anaheim, California, United States, 92801
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40509
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
Study complete
Actual primary completion date
2007-21-06
Actual study completion date
2007-21-06
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.
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