Safety and efficacy of TRO19622 in ALS Patients treated with riluzole.

• Research type

  Research Study

• Full title

  Phase II/III, multicenter, randomized, parallel group, double-blind, placebo controlled study to assess safety and efficacy of TRO19622 in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole.

• IRAS ID

  17239

• Sponsor organisation

  Business & Decision Life Sciences

• Eudract number

  2008-007320-25

• Clinicaltrials.gov Identifier

  NCT00868166

• Research summary

  This study will investigate whether a single daily dose of two capsules of a new drug named "TRO19622" administered over a period of 18 months can improve survival and symptoms in patients with ALS (Amyotrophic Lateral Sclerosis).The aim of the presenttrial is to obtain information about efficacy, safety and plasma levels of TRO19622 as add-on therapy to riluzole 50 mg bid in the treatment of patients suffering from ALS, as compared to placebo.This European project will involve hospital sites in France, hospital sites in Belgium, academic sites in the Netherlan's, academic and hospital sites in Germany and n's organ'sations in the UK.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/47

• Date of REC Opinion

  24 Jul 2009

• REC opinion

  Further Information Favourable Opinion