Last updated: 11/04/2018 10:31:31

12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome(CR-RLS)

Request patient level data
GSK study ID
RRL103660
See study documents
Clinicaltrials.gov ID
NCT00373542
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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:
  • Drug: ropinirole CR-RLS
    • 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
    • Inclusion criteria:
    • provided written informed consent.
    Inclusion and exclusion criteria
    Inclusion 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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Greenwood, Colorado, United States, 80111
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Macon, Georgia, United States, 31201
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Jasper, Alabama, United States, 35501
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40217
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Elk Grove Village, Illinois, United States, 60007
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Lenexa, Kansas, United States, 66214
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 45 Results

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    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.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website