Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)

• Status: Completed
• Trial end date: 2009-09-04
• Target enrollment: 0
• Participant gender: All

Summary

This was a 2-part study of dexpramipexole in patients with ALS.

Part 1 was a randomized, placebo-controlled, multi-center study to evaluate the safety, tolerability, and clinical effects of oral administration of 3 dosage levels of dexpramipexole vs. placebo for 12 weeks.

Part 2 was a randomized, double-blind, 2-arm, parallel group, extension study evaluating the safety, tolerability, and clinical effects of oral administration of 2 dosage levels of dexpramipexole for up to 72 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Knopp Biosciences
• Treatments: Pramipexole

Criteria

Inclusion Criteria:

• Patients with diagnosis of familial or sporadic ALS, defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria

• Patients with ALS symptom onset < 24 months from randomization

• Patients with upright vital capacity (VC) > 65% of predicted for age, height, and gender

Exclusion Criteria:

• Patients in whom causes of neuromuscular weakness other than ALS have not been excluded

• Patients without clinical evidence of upper motor neuron dysfunction

• Patients with clinically suspected ALS according to the World Federation of Neurology El Escorial criteria

• Patients with prior exposure to KNS-760704 or the R(+) enantiomer of pramipexole (i.e., R(+)-pramipexole)

• Patients taking other investigational agents (including lithium) within 30 days of randomization or during the study