Safety and Tolerability Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT00647296
Last Updated: 2021-07-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
194 participants
INTERVENTIONAL
2008-04-09
2009-09-04
Brief Summary
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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.
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Detailed Description
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In part 1, 102 subjects with ALS were randomized at 20 US sites to receive placebo, dexpramipexole at 50 mg/day; dexpramipexole at 150 mg/day; or dexpramipexole at 300 mg/day for 12 weeks. Participants who completed Part 1 were eligible to enroll into Part 2.
Part 2 was a randomized, double-blind, 2-arm, parallel-group, extension study evaluating the longer-term safety, tolerability, and clinical effects of oral administration of 2 dosage levels of dexpramipexole. In part 2, following a 4-week, placebo washout, continuing subjects received dexpramipexole at 50 mg/day or 300 mg/day as double-blind treatment for up to 72 additional weeks (Part 2 duration was up to a total of 76 weeks, including the 4 week placebo portion).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Part 1: Placebo or Dexpramipexole
During Part 1, subjects received twice daily doses of dexpramipexole (50 mg/day, 150 mg/day, or 300 mg/day) or matching placebo for approximately 12 weeks.
Placebo
Placebo: 2 tablets taken orally twice daily
Dexpramipexole 50 mg/day
Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily
Dexpramipexole 150 mg/day
Dexpramipexole: 2 x 37.5 mg tablets taken orally twice daily
Dexpramipexole 300 mg/day
Dexpramipexole: 2 x 75 mg tablets taken orally twice daily
Part 2: Placebo washout
At the beginning of Part 2, subjects received twice daily doses of placebo for approximately 4 weeks.
Placebo
Placebo: 2 tablets taken orally twice daily
Part 2: Dexpramipexole
Following the Part 2 placebo washout, subjects received dexpramipexole (50 mg/day or 300 mg/day), subjects received twice daily doses of placebo for up to 18 months.
Dexpramipexole 50 mg/day
Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily
Dexpramipexole 300 mg/day
Dexpramipexole: 2 x 75 mg tablets taken orally twice daily
Interventions
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Placebo
Placebo: 2 tablets taken orally twice daily
Dexpramipexole 50 mg/day
Dexpramipexole: 2 x 12.5 mg tablets taken orally twice daily
Dexpramipexole 150 mg/day
Dexpramipexole: 2 x 37.5 mg tablets taken orally twice daily
Dexpramipexole 300 mg/day
Dexpramipexole: 2 x 75 mg tablets taken orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 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
21 Years
80 Years
ALL
No
Sponsors
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Knopp Biosciences
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Cudkowicz M, Bozik ME, Ingersoll EW, Miller R, Mitsumoto H, Shefner J, Moore DH, Schoenfeld D, Mather JL, Archibald D, Sullivan M, Amburgey C, Moritz J, Gribkoff VK. The effects of dexpramipexole (KNS-760704) in individuals with amyotrophic lateral sclerosis. Nat Med. 2011 Nov 20;17(12):1652-6. doi: 10.1038/nm.2579.
Other Identifiers
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KNS-760704-CL201
Identifier Type: -
Identifier Source: org_study_id
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