Idiopathic Restless Legs Syndrome Clinical Trial
Official title:
A Phase 3 Multi-Center, Placebo-Controlled, Double Blind, 3-Armed Parallel Group, Comparative Study of SPM 962 4.5 and 6.75 mg/Day to Investigate Superiority to Placebo in Patients With Restless Legs Syndrome
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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