Status:
COMPLETED
Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)
Lead Sponsor:
Knopp Biosciences
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief 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 admi...
Detailed Description
This study was a two-part, multicenter, double-blind study in subjects with ALS to evaluate the safety and tolerability of dexpramipexole treatment, as well as the preliminary effects on measures of c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 9 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2009
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00647296
Start Date
April 9 2008
End Date
September 4 2009
Last Update
July 8 2021
Active Locations (21)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
UCLA, Dept. of Neurology - Neuromuscular/ALS Research Center
Los Angeles, California, United States, 90095
3
The Forbes Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
4
University of Colorado Health Sciences Center
Aurora, Colorado, United States, 80045