NCT01622088

Phase 3 Extension Study of Dexpramipexole in ALS

An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 616 (actual)
• Sponsor: Knopp Biosciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Dexpramipexole	Oral tablet 150 mg given twice daily (BID)

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-06-18
• Last updated: 2022-05-03
• Results posted: 2022-04-07

Locations

80 sites across 11 countries: United States, Australia, Belgium, Canada, France, Germany, Ireland, Netherlands, Spain, Sweden, United Kingdom