drugset / Trial / NCT00144209
Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome
RandomizedCrossoverDouble-blindTreatment
Summary
The primary objective of this study is to determine that pramipexole (Sifrol) 0.25 mg to 0.75 mg daily is not inferior to levodopa 100 mg to 300 mg (in combination with benserazide 25mg to 75mg = Madopar DR) daily in the treatment of patients with idiopathic restless legs syndrome fulfilling the International Diagnostic Criteria. The efficacy parameters include an objective measure of the leg movements during the time spent in bed, and a quantitative clinical assessment of the severity of RLS, in the form of the RLS-score. In addition, the efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome measures such as quality of life and sleep.
Timeline
- Start
- 2003-02
- Primary completion
- 2005-02
- Completion
- 2005-02
Publications
- Bassetti CL, Bornatico F, Fuhr P, Schwander J, Kallweit U, Mathis J; Swiss RLS study group. Pramipexole versus dual release levodopa in restless legs syndrome: a double blind, randomised, cross-over trial. Swiss Med Wkly. 2011 Nov 21;141:w13274. doi: 10.4414/smw.2011.13274. eCollection 2011.
- Kallweit U, Khatami R, Pizza F, Mathis J, Bassetti CL. Dopaminergic treatment in idiopathic restless legs syndrome: effects on subjective sleepiness. Clin Neuropharmacol. 2010 Nov-Dec;33(6):276-8. doi: 10.1097/WNF.0b013e3181fd82a1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Levodopa | Small molecule | 100 mg | — |
| Subject | Levodopa | Small molecule | 300 mg | — |
| Subject | Pramipexole | Unknown | 0.25 mg | — |
| Subject | Pramipexole | Unknown | 0.75 mg | — |
| Subject | benserazide | Small molecule | 25 mg | — |
| Subject | benserazide | Small molecule | 75 mg | — |