Safety and Efficacy of Dexpramipexole in Amyotrophic Lateral Sclerosis
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis
IRAS ID
70565
Contact name
Pamela J Shaw
Sponsor organisation
Biogen Idec Limited
Eudract number
2010-022818-19
Clinicaltrials.gov Identifier
Research summary
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of the Safety and Efficacy of Dexpramipexole in Subjects with Amyotrophic Lateral Sclerosis (ALS). The objective's of the study are to evaluate the efficacy, safety and pharmacokinetics of oral administration of dexpramipexole 300 mg/day (150 mg twice daily)compared to placebo for 12 months in subjects with ALS. Subjects will be randomly assigned in a 1:1 ratio to dexpramipexole 300 mg/day or matching placebo. Approximately 80 study centers will be recruited world wide with approximately 804 subjects enrolled. Subjects will remain on randomized, placebo-controlled, double-blind treatment until either the Month 18 visit or until the last subject completes the Month 12 visit, whichever comes sooner. When a subject has study treatment withdrawn prematurely, the subject will continue to be followed monthly through 18 months or until study completion, whichever comes first. Subjects who continue in the study until study completion (between 12 and 18 months, depending on their date of enrollment) will be offered the option to enter an open label extension study (under a separate protocol) at that time.
REC name
North West - Haydock Research Ethics Committee
REC reference
11/NW/0013
Date of REC Opinion
22 Mar 2011
REC opinion
Further Information Favourable Opinion