Phase IIa AZD3241 in Patients with Multiple System Atrophy

• Research type

  Research Study

• Full title

  A Phase IIa, Multi-Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel Group 12-Month Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD3241 in Patients with Multiple System Atrophy

• IRAS ID

  57496

• Contact name

  Kailash Bhatia

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2009-018157-23

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is being carried out to determine if AZD3241 is effective in treating multiple system atrophy (MSA). Multiple system atrophy (MSA) is a progressive neurodegenerative disorder which manifests with a number of clinical features which include Parkinsonism, autonomic failure and cerebellar features. This causes symptoms of slowness and tremor, faintness, giddiness or imbalance. There is no cure or effective treatments currently known for MSA. The effectiveness of AZD3241 on disease progression will be measured using scales and questionnaires. This study will also evaluate the safety and tolerability of AZD3241.There will be two groups of patients on this study. One group will receive placebo and the other group will receive AZD3241. Approximately 110 men and women at approximately 40 study centres in Europe, Israel, and North America will participate in this research study. Participants will be taking part in this study for 12 months

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/42

• Date of REC Opinion

  30 Sep 2010

• REC opinion

  Further Information Favourable Opinion