223AS304 Long Term Safety & Efficacy of Dexpramipexole in ALS

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis

• IRAS ID

  106393

• Contact name

  Pamela J Shaw

• Sponsor organisation

  Biogen Idec

• Eudract number

  2011-006119-70

• Research summary

  Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, degenerative disease of motor neurons in the brain and spinal cord that leads to muscle atrophy (wasting) and spasticity (muscle tightness) in limb and bulbar muscles (muscles in the face and throat) resulting in weakness and loss of ambulation (ability to walk), oro-pharyngeal dysfunction (weakness of the lips and tongue), weight loss, and ultimately respiratory failure. Study 223AS302 was a phase 3, randomized, double-blind, placebo-controlled, multi center study looking at the safety and efficacy of dexpramipexole in subjects with Amyotrophic Lateral Sclerosis (ALS). This study (223AS304) is an extension study to the above and will be further evaluating the long term safety and efficacy of dexpramipexole in these subjects. After completion of 223AS302, eligible subjects will be able to rollover into this extension study to receive oral administration of dexpramipexole 300 mg/day (150 mg twice daily); the same dose used in 223AS302. The duration of study treatment will be up to 36 months or until local regulatory approval is obtained in the UK and dexpramipexole is commercially available (unless approval is denied or the application is withdrawn by the Sponsor), whichever comes first. The follow-up period will be 30 days (up to 37 days) after the subject??s last dose of study treatment.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  12/NW/0413

• Date of REC Opinion

  10 Jul 2012

• REC opinion

  Further Information Favourable Opinion