At a glance
ClinicalIndex Comparison Record- ✓Age 18–85 years, male or female out-patients
- ✓Diagnosis of idiopathic RLS meeting all four IRLSSG clinical criteria
- ✓RLS symptoms present at least 2–3 days per week for the preceding 3 months
- ✓International RLS Study Group Severity Scale (IRLS) total score >15 at baseline
- ✕Known hypersensitivity to pramipexole or any component of the investigational product or placebo
- ✕History of augmentation under previous pharmacological RLS treatment
- ✕Any dopamine agonist intake within 14 days prior to baseline
- ✕Any levodopa intake within 14 days prior to baseline
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV Randomised, Double-blind, Placebo-controlled, Dose Titration Trial With Pramipexole (Sifrol, Mirapexin) 0.125-0.75 mg/Day Per os to Investigate the Long-term Efficacy, Safety and Tolerability in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome for 26 Weeks Followed by a 26 Week Open-label Extension Treatment Period
In Brief
A Phase 4 clinical trial evaluating Pramipexole and Placebo for Restless Legs Syndrome. Completed, enrolled 331 participants across 42 sites in 9 countries.
Detailed Summary
The primary objective of the current study will be the evaluation of long-term efficacy of a 26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless Legs Syndrome (RLS) in comparison to placebo. The key secondary objectives are to assess the effects on clinical global impressions - global improvement (CGI-I) (based on CGI-I responder rate) and on RLS (based on IRLS responder rate) for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to investigate the incidence and severity of augmentation and rebound and to assess the effects on patient global impression (PGI) (based on PGI responder rate), on RLS symptoms (based on the RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in limbs (based on a visual analogue scale (VAS)), on quality of life in RLS (based on Johns Hopkins RLS-QoL), on general quality of life Short Form 36 (SF-36) and on safety (based on adverse events (AE) profile) of pramipexole in comparison to placebo.