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A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome

NCT01562743 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2014-04-23

Study results available
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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.

Conditions

  • Idiopathic Restless Legs Syndrome

Interventions

DRUG

SPM 962

Tansdermal patch

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-10-31
Completion
2010-10-31

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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 NCT01562743 on ClinicalTrials.gov