Assessment of 1mg Rasagiline Mesylate in MSA-P subjects

• Research type

  Research Study

• Full title

  A Multi-centred, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Efficacy, Safety and Tolerability of Rasagiline Mesylate 1mg in Patients with Multiple System Atrophy of the Parkinsonian Subtype (MSA-P).

• IRAS ID

  32163

• Contact name

  Christopher J Mathias

• Sponsor organisation

  Teva Pharmaceuticals Ltd

• Eudract number

  2009-014644-11

• ISRCTN Number

  finished

• Research summary

  Is 1mg Rasagiline Mesylate clinically effective and safe to treat MSA-P patients? The primary objective of this study is to test the clinical effect of the drug 1mg Rasagiline Mesylate in subjects with MSA of the Parkinsonian subtype. The study is taking place in 8 European countries and Canada, USA and Israel. The study will be conducted at three specialist hospital centres within the UK. The study will last for 52 weeks. Rasagiline Mesylate (Azilect ©) has been granted marketing approval for the symptomatic treatment of Parkinson Disease (PD) by European, US and Canadian regulatory agencies. Subjects will be randomized to receive Rasagiline 1 mg/day or matching placebo and will be evaluated at the hospital centre by the study doctors for a total of six visits. Subjects will also be assessed by telephone calls between study visits at weeks 6, 18, 30, and 42. Subjects will be asked to undergo a number of clinical and safety assessments including physical examinations, Electrocardiograms (ECGs) and blood tests. Subjects will also be asked to complete a number of health related questionnaires.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  09/H0301/79

• Date of REC Opinion

  25 Jan 2010

• REC opinion

  Further Information Favourable Opinion