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

NCT01084551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2014-06-05

Study results available
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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

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

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01084551 on ClinicalTrials.gov