A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients

Idiopathic Restless Legs Syndrome Clinical Trial

Official title:
A Placebo-Controlled Study for SPM 962 in RLS Patients

Status Completed

Clinical Trial Summary

The primary objective of this study is to investigate efficacy and safety of SPM 962 in Japanese RLS patients in a multi-center, placebo-controlled double-blind parrallel group comparative study following once-daily multiple transdermal doses of SPM 962 within a range of 2.25 to 6.75 mg/day. Recommended maintainance dose range is also to be investigated.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Idiopathic Restless Legs Syndrome
Psychomotor Agitation
Restless Legs Syndrome

Clinical Trial Details

NCT number	NCT00666965
Study type	Interventional
Source	Otsuka Pharmaceutical Co., Ltd.
Contact
Status	Completed
Phase	Phase 2
Start date	June 2008
Completion date	August 2009

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00390689` - A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.	Phase 3
Completed	`NCT01113710` - Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise	N/A
Completed	`NCT00498108` - Phase 3 Open-label Extension Trial With Rotigotine in Idiopathic Restless Legs Syndrome Subjects	Phase 3
Completed	`NCT01084551` - Study of SPM 962 in Patients With Restless Legs Syndrome (RLS)	Phase 3
Completed	`NCT00806026` - Long Term Study Of Pregabalin In Idiopathic Restless Legs Syndrome Patients	Phase 3
Completed	`NCT01562743` - A Long-Term Extension Trial From Late Phase II of SPM 962 in Patients With Restless Legs Syndrome	Phase 2