Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this trial is to compare an individually optimized dose of the lisuride TTS patch against placebo and against an individually optimized dose of oral ropinirole (active- and placebo-controlled design) in idiopathic and uremic RLS patients with regard to efficacy, safety, and quality of life.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Axxonis Pharma AG
• Treatments: Lisuride; Ropinirole

Criteria

Inclusion Criteria:

• Idiopathic or uremic RLS

• RLS Diagnostic Index (RLS-DI) > 10

• Total score in the IRLS Rating Scale ≥ 15 at baseline

• No previous treatment for RLS or insufficient current therapy

Exclusion Criteria:

• Secondary RLS, e.g. due to iron deficiency (exception: uremia)

• History or presence of sleep disorders other than RLS