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

Completed · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT00647296

Run by

Knopp Biosciences

People needed

194

Starts

2008-04-09

Expected to finish

2009-09-04

Last updated by the study team

2021-07-08

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• UCLA, Dept. of Neurology - Neuromuscular/ALS Research Center — Los Angeles, California, United States
• The Forbes Norris MDA/ALS Research Center — San Francisco, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University School of Medicine — Baltimore, Maryland, United States
• Massachusettes General Hospital — Boston, Massachusetts, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Bryan LGH Medical Center East — Lincoln, Nebraska, United States
• Columbia University, Lou Gehrig MDA/ALS Research Center — New York, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States
• Drexel University College Of Medicine — Philadelphia, Pennsylvania, United States
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Health Sciences Center of San Antonio — San Antonio, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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