NCT01281189

Phase 3 Study of Dexpramipexole in ALS

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of the Safety and Efficacy of Dexpramipexole in Subjects With Amyotrophic Lateral Sclerosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 942 (actual)
• Sponsor: Knopp Biosciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Dexpramipexole	Oral tablet 150mg twice daily for up to 18 months.
DRUG	Placebo	Oral tablet twice daily for up to 18 months.

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-01-21
• Last updated: 2021-06-07
• Results posted: 2021-06-07

Locations

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