Conditions: Idiopathic Restless Legs Syndrome
Keywords: SPM 962 rotigotine Idiopathic Restless Legs Syndrome RLS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 230
Healthy volunteers: no

Brief summary:
The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.

Detailed description:

Arms:
arm 1: inactive placebo arm 2: 2.25 mg first week: 2.25 mg 1 sheet plus placebo 1 sheet 2nd to 6th week :2.25mg 1 sheet plus placebo 2 sheets arm 3: 4.5 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 2 sheets pus placebo 1 sheet arm 4: 6.75 mg/body first week : 2.25 mg 2 sheets 2nd to 6th week : 2.25 mg 3sheets

Interventions: intervention 1: SPM 962
Intervention descriptions: intervention 1: transdermal application, 1 time per day, 0-6.75 mg/body, titration, 6weeks

Protocol document: