A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.

Idiopathic Restless Legs Syndrome Clinical Trial

Official title:
A Randomised, Double-blind Study to Evaluate the Efficacy and Safety of Pramipexole at Fixed Doses of 0.25 mg, 0.5 mg, and 0.75 mg in Patients With Idiopathic Restless Legs Syndrome for 6 Weeks, Followed by a 46-week Open-label Long-term Study

Status Completed

Clinical Trial Summary

The objective of double blind phase in this trial is to compare the efficacy and safety at the fixed dose of 0.25 mg,0.5 mg and 0.75 mg pramipexole in RLS. The objective of open label phase in this trial is to investigate the long term safety and efficacy of pramipexole in RLS.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, 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	NCT00390689
Study type	Interventional
Source	Boehringer Ingelheim
Contact
Status	Completed
Phase	Phase 3
Start date	October 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01113710` - Non-interventional Study (NIS) in Patients With Restless Legs Syndrome in Daily Practise	N/A
Completed	`NCT00666965` - A Placebo-Controlled Study for SPM 962 in Restless Legs Syndrome (RLS) Patients	Phase 2
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