Phase 3 Study of Dexpramipexole in ALS

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Knopp Biosciences
• Treatments: Pramipexole

Criteria

Inclusion Criteria:

• Aged 18 to 80 years old, inclusive, on Day 1.

• Diagnosis of sporadic or familial ALS.

• Onset of first ALS symptoms within 24 months prior to Day 1.

• World Federation of Neurology El Escorial criteria are met for a possible, laboratory-supported probable, probable, or definite ALS diagnosis.

• Upright slow vital capacity (SVC) of 65% or more at screening.

• Patients taking or not taking Riluzole are eligible for this study: if a patient has never taken Riluzole, he or she is eligible; if a patient is currently taking Riluzole, he or she must have been on a stable dose for at least 60 days; if a patient has discontinued Riluzole, he or she must have stopped taking it for at least 30 days.

• Must be able to swallow tablets at the time of study entry.

Exclusion Criteria:

• Other medically significant illness.

• Clinically significant abnormal laboratory values.

• Pregnant women or women breastfeeding.

• Prior exposure to dexpramipexole.

• Currently taking pramipexole or other dopamine agonists.

Other protocol-defined inclusion/exclusion criteria may apply.