Biogen, Knopp begin enrollment in ALS drug study

The randomised, double-blind, placebo-controlled, parallel-group, multi-centre Phase III study will evaluate the safety and efficacy dexpramipexole in people with familial or sporadic ALS.

The study will enroll approximately 804 patients, who will receive dexpramipexole 150 mg twice daily or placebo.

The patients will be followed for a period of at least 12 months.

The primary objective of the study will be evaluated using a joint ranking of functional outcomes adjusted for mortality on the ALS Functional Rating Scale, Revised (ALSFRS-R) which is used to monitor the progression of disability in ALS patients.