ASP8825 - Study in Patients With Restless Legs Syndrome

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc

Criteria

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