Conditions: Idiopathic Restless Legs Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 284
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the clinical efficacy and safety of SPM962 in patients with restless legs syndrome (RLS) with once-daily repeated doses of 4.5mg and 6.75mg during a 13-week dose-titration and maintenance period. This is a multi-center, randomized, placebo-controlled, double-blind, 3-armed parallel group comparison study.

Efficacy will be determined by investigating the superiority of SPM962 to placebo in terms of the primary efficacy variable, change in International Restless Legs Syndrome Rating Scale (IRLS) total score from baseline to the end of the dose-maintenance period.

Detailed description:

Arms:
arm 1: started at 2.25 mg/day to 4.5 mg/day for 13 weeks arm 2: started at 2.25 mg/day to 6.75 mg/day for 13 weeks arm 3: for 13 weeks

Interventions: intervention 1: SPM 962 intervention 2: SPM 962 intervention 3: Placebo of SPM 962
Intervention descriptions: intervention 1: once a daily transdermal administration started at 2.25 mg/day to 4.5 mg/day for 13 weeks intervention 2: once a daily transdermal administration started at 2.25 mg/day to 6.75 mg/day for 13 weeks intervention 3: once a daily transdermal administration for 13 weeks

Protocol document: