Rotigotine Restless Legs Syndrome Dose Finding Trial

Idiopathic Restless Leg Syndrome Clinical Trial

Official title: Multi-center, Double-blind, Randomized, Placebo-controlled, Six-arm, Parallel-group, Dose-finding Trial to Determine Efficacy, Safety and Tolerability of Five Different Transdermal Doses of Rotigotine in Subjects With Idiopathic Restless Leg Syndrome

Status Completed

Clinical Trial Summary

The objective of this trial is to demonstrate clinical efficacy of four different dosages of SPM 962 1.125 mg, 2.25 mg, 4.5 mg and 6.75 mg (corresponding to 2.5 cm2, 5 cm2, 10 cm2 and 15 cm2 patch size respectively) in RLS subjects. It is anticipated that rotigotine (SPM 936) will be more effective than placebo. The tolerability and safety of rotigotine will be assessed.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Restless Leg Syndrome
• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

• NCT number: NCT00243217
• Study type: Interventional
• Source: UCB Pharma
• Status: Completed
• Phase: Phase 2
• Start date: April 2003
• Completion date: February 2004