Overview

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