Restless Legs Syndrome
Conditions
Keywords
Restless Legs Syndrome, dopamine agonist, lisuride, ropinirole
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-controlled design) in idiopathic and uremic RLS patients with regard to efficacy, safety, and quality of life.
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 the option to continue treatment with the lisuride patch for further 36 weeks in an open-label extension of the study. Primary outcome: Changes in the total score of the International Restless Legs Severity Scale (IRLS) from baseline to end of double-blind treatment (12 weeks) will be used as primary efficacy outcome measure. Secondary objectives are to evaluate quality of life, safety and tolerability. After the double-blind period, long-term efficacy of lisuride will be assessed for further 36 weeks in an open-label extension of the study.
Interventions
Sponsors
Axxonis Pharma AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Restless Legs Severity Scale (IRLS) | — |
Secondary
| Measure | Time frame |
|---|---|
| RLS-6 scales | — |
| CGI | — |
Countries
Germany
Outcome results
None listed