Restless Legs Syndrome Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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|---|---|---|---|
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