Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
NCT00367822 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2012-03-07
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.
Conditions
- Restless Legs Syndrome
Interventions
- DRUG
-
Lisuride
- DRUG
-
Ropinirole
- DRUG
Sponsors & Collaborators
-
Axxonis Pharma AG
lead INDUSTRY
Principal Investigators
-
Heike Benes, MD · Somnibene GmbH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
Countries
- Germany
Study Locations
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