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An Open-Label, Safety and Tolerability, Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS)
This is an open-label, multi-center study designed to extend the evaluation of the safety, tolerability, and clinical effects of oral administration of KNS-760704 in patients with ALS.
Patients who complete the Part 2 Week 28 visit in study KNS-760704-CL201 and patients with ALS who were actively receiving RTPB \[(6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydro-chloride monohydrate\] under Research IND #60,948 were eligible to participate in this study. Eligible patients received 1 tablet of KNS-760704 (150 mg) every 12 hours (Q12H) (300 mg total daily dose) for up to 180 weeks.
Age
21 - 80 years
Sex
ALL
Healthy Volunteers
No
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 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
Start Date
July 1, 2009
Primary Completion Date
July 1, 2013
Completion Date
July 1, 2013
Last Updated
August 16, 2021
74
ACTUAL participants
KNS-760704
DRUG
Lead Sponsor
Knopp Biosciences
NCT07322003
NCT05104710
NCT07357428
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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