Last updated: 07/18/2020 12:11:11
Converting From Ropinirole Immediate Release (IR) To Ropinirole Controlled-Release for RLS (Restless Legs Syndrome)
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 4-Week, Randomized, Double-Blind, Cohort Study to Evaluate the Safety and Tolerability of Converting from Ropinirole Immediate Release (IR) to Ropinirole Controlled Release for RLS (CR-RLS) Formulation (Formerly Ropinirole Extended Release [XR]) in Patients with Restless Legs Syndrome (RLS)
Trial description: This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Number of adverse events (AEs) post-conversion from ropinirole IR to ropinirole CR over period
Timeframe: Up to 5 weeks
Secondary outcomes:
Number of participants discontinuing the drug due to AEs post conversion from ropinirole IR to ropinirole CR-RLS
Timeframe: Up to 5 weeks
Number of participants with SAEs and severity of AEs
Timeframe: Up to 5 weeks
Number of participants with positive scores (improved) on clinical global impression improvement scale (CGI-I) pre-conversion and one week post-conversion
Timeframe: Up to 4 weeks
Change from pre-conversion in international RLS (IRLS) rating scale total score to one week post-conversion
Timeframe: Up to 5 weeks
Number of participants with pre-and one week post-conversion values of vital signs of potential clinical concern (PCC)
Timeframe: Up to 5 weeks
Change from pre-conversion in systolic and diastolic orthostatic SBP and DBP to one week post-conversion
Timeframe: Up to 5 weeks
Change from pre-conversion in pulse rate to one week post-conversion
Timeframe: Up to 5 weeks
Change from pre-conversion to post-conversion in ambulatory blood pressure
Timeframe: Up to 5 weeks
Interventions:
Drug: Ropinirole IR 1 mg
Drug: Ropinirole IR 2 mg
Drug: Ropinirole IR 1 mg Placebo
Drug: Ropinirole IR 2 mg Placebo
Drug: Ropinirole CR 2 mg
Drug: Ropinirole CR 3 mg
Drug: Ropinirole CR 2 mg Placebo
Drug: Ropinirole CR 3 mg Placebo
Enrollment:
135
Observational study model:
Not applicable
Primary completion date:
2006-21-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Restless Legs Syndrome
Product
ropinirole
Collaborators
Not applicable
Study date(s)
November 2005 to September 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18 - 79 years
Accepts healthy volunteers
No
- Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.
- Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.
- Subjects who require treatment of daytime RLS symptoms.
- Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of RLS using IRLS Study Group (IRLSSG) diagnostic criteria.
- Subjects currently being treated for RLS with a stable dose (for at least 2 weeks) of ropinirole IR given once daily.
- Subjects with RLS symptoms during both the evening and night or night time only.
- Subjects who have given written informed consent to participate.
Exclusion criteria:
- Subjects who require treatment of daytime RLS symptoms.
- Signs of secondary RLS, serum ferritin level less than 10 mcg/L.
- Movement Disorders, Clinically significant or unstable medical conditions.
- Abnormal labs, electrocardiogram (ECG) or physical findings.
- Receiving prohibited medications.
- Sleeping habits incompatible with study design.
- Intolerance to ropinirole or other dopamine agonist.
- Pregnant or lactating.
- Women of child-bearing potential who are not practicing an acceptable method of birth control.
Trial location(s)
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30342
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
Status
Study Complete
Location
GSK Investigational Site
Laguna Hills, California, United States, 82653
Status
Study Complete
Location
GSK Investigational Site
Cherry Hill, New Jersey, United States, 08003
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boca Raton, Florida, United States, 33486
Status
Study Complete
Location
GSK Investigational Site
Medford, Oregon, United States, 97504-8456
Status
Study Complete
Location
GSK Investigational Site
Oxnard, California, United States, 93030
Status
Study Complete
Location
GSK Investigational Site
Plainview, New York, United States, 11803
Status
Study Complete
Location
GSK Investigational Site
Pasadena, California, United States, 91106
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Reseda, California, United States, 91355
Status
Study Complete
Location
GSK Investigational Site
Lebanon, New Hampshire, United States, 03766
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53715
Status
Study Complete
Location
GSK Investigational Site
Greenville, North Carolina, United States, 27834
Status
Study Complete
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
Las Vegas, Nevada, United States, 89119
Status
Study Complete
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01104
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10021
Status
Study Complete
Location
GSK Investigational Site
Columbia, South Carolina, United States, 29201
Status
Study Complete
Location
GSK Investigational Site
Bingham Farms, Michigan, United States, 48025
Status
Study Complete
Location
GSK Investigational Site
Toms River, New Jersey, United States, 08755
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33701
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
2006-21-09
Actual study completion date
2006-21-09
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 hereAccess to clinical trial data by researchers
Visit website