Conditions: Idiopathic Restless Legs Syndrome
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 185
Healthy volunteers: no

Brief summary:
The aims of the trial are to assess the safety and the efficacy of SPM 962 following once-a-daily transdermal administration within a range of 2.25 to 6.75 mg/day in Japanese patients with restless legs syndrome (RLS) in a multi-center, open-label trial. The maximum treatment period is 53 weeks. The trial is an extension trial from the precedent 6-week, double-blind, randomized, placebo-controlled, parallel-group comparative trial(243-07-003). The trial is also for an exploratory investigation of incidence of augmentation, the most problematic complications in dopaminergic treatment.

Detailed description:

Arms:
arm 1: Rotigotine transdermal patch

Interventions: intervention 1: SPM 962
Intervention descriptions: intervention 1: Tansdermal patch

Protocol document: