A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

UCB

Status and phase: Completed; Phase 3

Conditions: Restless Legs Syndrome

Treatments: Drug: Rotigotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00275236

SP0794

2005-002814-39 (EudraCT Number)

Details and patient eligibility

About

The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total time in bed) as measured by polysomnography (PSG). The primary variable is the reduction of PLMI at the end of the Maintenance Period compared to Baseline. PLMI data will be obtained from PSGs.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Idiopathic RLS

Exclusion criteria

• secondary RLS
• history of sleep disturbances
• symptomatic orthostatic hypotension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind