Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
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.