Status:
COMPLETED
Transdermal Lisuride: a Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)
Lead Sponsor:
Axxonis Pharma AG
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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-co...
Detailed Description
Approximately 300 patients will be randomized to receive either lisuride, ropinirole or placebo in a 2:1:1 fashion. After completion of 12 weeks of double-blind treatment, eligible patients will have ...
Eligibility Criteria
Inclusion
- 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
- Secondary RLS, e.g. due to iron deficiency (exception: uremia)
- History or presence of sleep disorders other than RLS
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00367822
Last Update
March 7 2012
Active Locations (1)
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1
IMEREM GmbH
Nuremberg, Germany