Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)
NCT ID: NCT00931944
Last Updated: 2021-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2009-07-31
2013-07-31
Brief Summary
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Detailed Description
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Eligible patients received 1 tablet of KNS-760704 (150 mg) every 12 hours (Q12H) (300 mg total daily dose) for up to 180 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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KNS-760704 300 mg/day
Open-label KNS-760704 (150 mg Q12H)
KNS-760704
150 mg Q12H KNS-760704 given orally (300 mg total daily dose)
Interventions
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KNS-760704
150 mg Q12H KNS-760704 given orally (300 mg total daily dose)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient is actively participating in Knopp Protocol KNS-760704-CL201 and has completed the Part 2 Week 28 visit in that study or patient is actively receiving RTPB under Research IND #60,948
Exclusion Criteria
2. Patient discontinued from KNS-760704-CL201 for any reason other than enrollment into this study (applies to patients enrolled in KNS-760704-CL201 only)
3. Patient was not taking RTPB under Research IND #60,948 prior to April 30, 2009 (applies to patients enrolled under Research IND #60,948 only)
21 Years
80 Years
ALL
No
Sponsors
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Knopp Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Merit Cudkowicz, M.D., MSc
Role: PRINCIPAL_INVESTIGATOR
NeuroClinical Trials Unit (Massachusetts General Hospital)
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 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
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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Other Identifiers
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KNS-760704-CL211
Identifier Type: -
Identifier Source: org_study_id
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