Last updated: 11/06/2018 23:16:11
A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A 12-week, double-blind, placebo-controlled, parallel group study to assess the efficacy and safety of intermittent dosing of ropinirole in patients with Restless Legs Syndrome (RLS)
Trial description: A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Average proportion of nights a subject has successfully treated his/her RLS symptoms after taking study medication for that night out of total number of nights dosed during the Double-Blind Phase.
Timeframe: 12 Weeks
Secondary outcomes:
Quality and satisfaction with sleep, severity of symptoms 2 hours post dosing with study medication.
Timeframe: 12 Weeks
Interventions:
Enrollment:
140
Primary completion date:
Not applicable
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)
January 2005 to December 2005
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 79 years
Accepts healthy volunteers
No
- Patients diagnosed with Restless Legs Syndrome (RLS).
- Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement).
- Patients with a primary sleep disorder other than RLS.
- Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).
Inclusion and exclusion criteria
Inclusion criteria:
- Patients diagnosed with Restless Legs Syndrome (RLS).
- Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement).
- Patients must give written informed consent prior to any specific study procedures.
Exclusion criteria:
- Patients with a primary sleep disorder other than RLS.
- Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).
- Other inclusion or exclusion criteria to be evaluated by the physician.
Trial location(s)
Location
GSK Investigational Site
Newton, Massachusetts, United States, 02459
Status
Study Complete
Location
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
Status
Study Complete
Location
GSK Investigational Site
Flossmoor, Illinois, United States, 60422
Status
Study Complete
Location
GSK Investigational Site
Edison, New Jersey, United States, 08818
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fairfield, Connecticut, United States, 06824
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87108
Status
Study Complete
Location
GSK Investigational Site
Lafayette Hill, Pennsylvania, United States, 19444
Status
Study Complete
Location
GSK Investigational Site
Santa Monica, California, United States, 90404
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Wenatchee, Washington, United States, 98801
Status
Study Complete
Location
GSK Investigational Site
New Hyde Park, New York, United States, 11040
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
Status
Study Complete
Location
GSK Investigational Site
Elk Grove Village, Illinois, United States, 60007
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Alabaster, Alabama, United States, 35007
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
Status
Study Complete
Location
GSK Investigational Site
Amherst, New York, United States, 14226
Status
Study Complete
Location
GSK Investigational Site
Concinnati, Ohio, United States, 45219
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70808
Status
Study Complete
Location
GSK Investigational Site
Newton Center, Massachusetts, United States, 02459
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60611
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Redondo Beach, California, United States, 90277
Status
Study Complete
Location
GSK Investigational Site
Pembroke Pines, Florida, United States, 33026
Status
Study Complete
Location
GSK Investigational Site
Oxnard, California, United States, 93030
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Location
GSK Investigational Site
Walla Walla, Washington, United States, 99362
Status
Study Complete
Location
GSK Investigational Site
Frederick, Maryland, United States, 21702
Status
Study Complete
Location
GSK Investigational Site
Northridge, California, United States, 91325
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
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-07-12
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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