Status:
COMPLETED
A Clinical Research Study Testing Ropinirole Treatment for Restless Legs Syndrome
Lead Sponsor:
GlaxoSmithKline
Conditions:
Restless Legs Syndrome (RLS)
Restless Legs Syndrome
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
A 14-Week clinical research study to compare the effectiveness and safety of ropinirole and placebo (an inactive sugar pill) in the treatment of patients with Restless Legs Syndrome (RLS) in the Unite...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients diagnosed with Restless Legs Syndrome (RLS) with symptoms such as: uncomfortable or "creepy-crawly" sensations in your legs, overwhelming urge to move your legs to relieve these sensations, sensations go away when you move your legs, or trouble falling asleep or staying asleep because of these symptoms.
- Patients must give written informed consent prior to any specific study procedures.
- Exclusion criteria:
- Patients who suffer from narcolepsy, sleep terror disorder, sleepwalking disorder, or a breathing related sleep disorder.
- Patients diagnosed with renal failure (end-stage renal disease) iron deficient anemia or pregnancy.
- Patients suffering from other movement disorders (i.e. Parkinson's Disease).
- Patients who have medical conditions such as diabetes, peripheral neuropathy, rheumatoid arthritis, or fibromyalgia syndrome.
- Participation in any clinical drug or device trial in the last three months.
- Other inclusion or exclusion criteria to be evaluated by the physician.
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00363857
Start Date
August 1 2003
End Date
May 1 2004
Last Update
October 17 2016
Active Locations (49)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Alabaster, Alabama, United States, 35007
2
GSK Investigational Site
Birmingham, Alabama, United States, 35294
3
GSK Investigational Site
Jasper, Alabama, United States, 35501
4
GSK Investigational Site
Tuscaloosa, Alabama, United States, 35406