A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome
Status:
Completed
Trial end date:
2010-10-01
Target enrollment:
Participant gender:
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.