Last updated: 11/02/2018 23:31:10
RLS In Adults: Comparing Immediate Release Formulation With Extended Release Formulation Of Ropinirole
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12-Week, Randomized, Double-Blind, Parallel Group, Multicentre Study to Assess the Tolerability and Clinical Benefits of Ropinirole Extended Release (XR) Tablets Compared with Ropinirole Immediate Release (IR) Tablets in Subjects with Restless Legs Syndrome (RLS)
Trial description: Restless Legs Syndrome (RLS) study in adults comparing immediate release ropinirole with extended release ropinirole over 12 weeks
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of participants with adverse event (AE) of nausea during the first 3 weeks fixed dose titration of ropinirole IR and ropinirole CR- RLS
Timeframe: Baseline (Day 0) up to Week 3
Secondary outcomes:
Number of participants with mild, moderate and severe nausea during the first 3 weeks fixed dose titration of ropinirole CR- RLS and ropinirole IR
Timeframe: Baseline (Day 0) to Week 3
Number of participants with most common AE (reported by 10 % or more of participants from either treatment group) during the first 3 weeks fixed dose titration of ropinirole IR and ropinirole CR- RLS
Timeframe: Baseline (Day 0) up to Week 3
Number of participants with the mild, moderate and severe most common AE (reported by 10% or more of participants from either treatment group) during the first 3 weeks fixed dose titration of ropinirole IR and ropinirole CR- RLS
Timeframe: Baseline (Day 0) up to Week 3
Number of participants with AE during the entire 12 week on treatment phase
Timeframe: Baseline (Day 0) up to Week 12
Number of participants with mild, moderate and severe AE during the entire 12 week on treatment phase
Timeframe: Baseline (Day 0) up to Week 12
Number of participants with dose reductions due to lack of tolerability between Weeks 3 and 12
Timeframe: Week 3 to Week 12
Number of participants with withdrawals due to lack of tolerability during the first 3 weeks fixed dose titration, and during the entire 12 week on treatment phase
Timeframe: Baseline (Day 0) up to Week 12
Number of participants with withdrawals due to insufficient therapeutic effect during the entire 12 week on treatment phase
Timeframe: Baseline (Day 0) up to Week 12
Mean change from Baseline in number of h of RLS symptoms during the evening, and during the evening and night time at Week 12
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline in number of h of RLS symptoms that were either absent or of maximal severity of mild during the evening, and during the evening and night time at Week 12
Timeframe: Baseline (Day 0) and Week 12
Percentage of treated days, which were RLS symptom-free
Timeframe: Baseline (Randomization, Day 0) up to Week 12
Median time to onset of the first 4 consecutive days that were completely RLS symptom-free within the first 4 weeks of the treatment phase
Timeframe: Baseline (Randomization, Day 0) up to Week 4
Mean change from Baseline in the International RLS (IRLS) Rating Scale total score at Weeks 1, 2, 3, 4, 8, and 12 for observed cases (OC)
Timeframe: Baseline (Day 0) up to Week 12
Mean change from Baseline in the IRLS Rating Scale total score at Weeks 12 LOCF
Timeframe: Baseline (Day 0) and Week 12
Number of participants with a score of Much improved (2) or Very much improved (1) on the CGI-I scale between Week 1 and Week 12 (OC)
Timeframe: Week 1 to Week 12
Number of participants with a score of Much improved (2) or Very much improved (1) on CGI-I scale at Week 12 (LOCF)
Timeframe: Week 12
Median time to response on the CGI-I scale
Timeframe: Baseline (Day 0) to Week 12
Mean change from Baseline in the Sleep Disturbance Domain of the 12-item Medical Outcomes Study (MOS-12) Sleep Scale at Week 12
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline in the Sleep Quantity Domain of the MOS-12 Sleep Scale at Week 12
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline in the Sleep Adequacy Domain of the MOS-12 Sleep Scale at Week 12
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline in the Somnolence Domain of the MOS-12 Sleep Scale at Week 12
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline in the Sleep Problems Index I of the MOS-12 Sleep Scale at Week 12
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline in the Sleep Problems Index II of the MOS-12 Sleep Scale at Week 12
Timeframe: Baseline (Day 0) and Week 12
Mean change from Baseline in the overall life impact score of the Johns Hopkins RLS Quality of Life Questionnaire at Week 12
Timeframe: Baseline (Day 0) and Week 12
Interventions:
Enrollment:
563
Primary completion date:
2006-15-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Restless Legs Syndrome
Product
ropinirole
Collaborators
Not applicable
Study date(s)
February 2006 to December 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 79 years
Accepts healthy volunteers
No
- Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
- Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.
- Signs of secondary RLS.
- Primary sleep disorder or movement disorder other than RLS.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria.
- Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring treatment.
Exclusion criteria:
- Signs of secondary RLS.
- Primary sleep disorder or movement disorder other than RLS.
- Unstable medical conditions.
- Inability to tolerate dopamine agonists or dopamine antagonists.
- Unwilling to discontinue any medications currently being taken to treat RLS symptoms.
Trial location(s)
Location
GSK Investigational Site
Redondo Beach, California, United States, 90277
Status
Study Complete
Location
GSK Investigational Site
West Yarmouth, Massachusetts, United States, 02673
Status
Study Complete
Location
GSK Investigational Site
Winnetka, California, United States, 91306
Status
Study Complete
Location
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19053
Status
Study Complete
Location
GSK Investigational Site
Frome, Somerset, United Kingdom, BA11 1EZ
Status
Study Complete
Showing 1 - 6 of 92 Results
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
2006-15-12
Actual study completion date
2006-15-12
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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