Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS, Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 616
Healthy volunteers: no

Brief summary:
The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

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 collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

Arms:
arm 1: Dexpramipexole open-label

Interventions: intervention 1: Dexpramipexole
Intervention descriptions: intervention 1: Oral tablet 150 mg given twice daily (BID)

Protocol document: