OLE safety study of TRO19622 for ALS patients treated with riluzole

• Research type

  Research Study

• Full title

  "An Open Label safety Extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated with riluzole."

• IRAS ID

  67192

• Contact name

  Pr Ammar AL CHALABI

• Sponsor organisation

  TROPHOS

• Eudract number

  2010-021179-10

• ISRCTN Number

  finished

• Research summary

  The objective of this study is to allow patients to be treated by olesoxime in an open label safety extension following their participation to a randomised study and to provide additional safety data on olesoxime (TRO19622). This a multicenter open label safety extension study of olesoxime (TRO19622) in Amyotrophic Lateral Sclerosis (ALS) patients treated wwith riluzole. Each patient will be treated with olesoxime (TRO19622) up to a maximum duration of 15 months.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  11/EE/0023

• Date of REC Opinion

  18 Apr 2011

• REC opinion

  Further Information Favourable Opinion