ASP8825 - Study in Patients With Restless Legs Syndrome
Phase 2
Completed
- Conditions
- Restless Legs Syndrome
- Interventions
- Drug: ASP8825Drug: Placebo
- Registration Number
- NCT00530530
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome
- Detailed Description
Three doses of ASP8825 are compared to placebo in efficacy and safety point of view in patients with restless legs syndrome
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 474
Inclusion Criteria
- Patients with RLS, based on the International RSL Study Group Diagnostic Criteria
- History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started
- Documented RLS symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period
Exclusion Criteria
- A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
- A history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
- Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias and dystonias
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 ASP8825 Dose 3 1 ASP8825 Dose 1 4 Placebo - 2 ASP8825 Dose 2
- Primary Outcome Measures
Name Time Method The change of the International Restless Legs Syndrome rating scale score 12 weeks
- Secondary Outcome Measures
Name Time Method Investigator-related Clinical Global Impression of Improvement 12 weeks Patient- related Clinical Global Impression of Improvement 12 weeks The Pittsburgh sleep quality index 12 weeks The SF-36 Health Survey 12 weeks The Restless Legs Syndrome QOL Questionnaire 12 weeks The Medical Outcomes Study sleep scale 12 weeks