Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis ALS Motor Neurone Disease Motor Neuron Disease Lou Gehrig's disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 942
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of Amyotrophic Lateral Sclerosis (ALS).

Detailed description:
Amyotrophic Lateral Sclerosis (ALS) is a rapidly progressive, degenerative disease of motor neurons in the brain and spinal cord that leads to muscle atrophy and spasticity in limb and bulbar muscles resulting in weakness and loss of ambulation, oropharyngeal dysfunction, weight loss, and ultimately respiratory failure. The purpose of this study is to determine whether dexpramipexole (150 mg twice daily) is safe and effective in the treatment of ALS.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Dexpramipexole intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablet 150mg twice daily for up to 18 months. intervention 2: Oral tablet twice daily for up to 18 months.

Protocol document: