Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome
- Conditions
- Restless Legs Syndrome
- Registration Number
- NCT00144209
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Frequency of periodic limb movements while in bed (PLM-I) after 4 weeks
- Secondary Outcome Measures
Name Time Method Changes in Quality of Life (SF-36) after 4 weeks Changes in sleep quality as assessed in a sleep diary after 4 weeks Changes in RLS-score after 4 weeks Mood changes measured by Hospital Anxiety and Depression Scale (HAD) after 4 weeks Overall impression assessed by Clinical Global Impression (CGI) after 4 weeks Changes in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS) after 4 weeks Incidence and Intensity of Adverse events up to 10 weeks Changes in safety laboratory values up to 10 weeks
Trial Locations
- Locations (1)
Boehringer Ingelheim Investigational Site
🇨🇭Zurzach, Switzerland