Biogen and Knopp Biosciences have enrolled the first patient in a Phase III study to evaluate dexpramipexole as a treatment for amyotrophic lateral sclerosis.
The randomised, double-blind, placebo-controlled, parallel-group and multi-centre Phase III study will evaluate the safety and efficacy of dexpramipexole in people with familial or sporadic amyotrophic lateral sclerosis.
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The study will enrol approximately 800 patients, who will be randomised in one-to-one ratio to receive either dexpramipexole 150mg twice-daily or a 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 Amyotrophic Lateral Sclerosis Functional Rating Scale, Revised, which is used to monitor the progression of disability.
Amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease, is a fatal neurodegenerative disorder characterised by progressive muscle weakness and wasting.
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