NCT01084551

Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Idiopathic Restless Legs Syndrome

Interventions

Type	Name	Description
DRUG	SPM 962	once a daily transdermal administration started at 2.25 mg/day to 4.5 mg/day for 13 weeks
DRUG	SPM 962	once a daily transdermal administration started at 2.25 mg/day to 6.75 mg/day for 13 weeks
DRUG	Placebo of SPM 962	once a daily transdermal administration for 13 weeks

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2010-03-10
• Last updated: 2014-06-05
• Results posted: 2014-06-05

Locations

8 sites across 1 country: Japan