Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)

Completed · Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT00931944

Run by

Knopp Biosciences

People needed

74

Starts

2009-07-01

Expected to finish

2013-07-01

Last updated by the study team

2021-08-16

Who can join

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

You may qualify if…

• Patient has provided signed informed consent for this trial before the commencement of any study-related procedure
• 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

You may not qualify if…

• Patient did not participate in Knopp Protocol KNS-760704-CL201 or patient did not receive RTPB under Research IND #60,948.
• Patient discontinued from KNS-760704-CL201 for any reason other than enrollment into this study (applies to patients enrolled in KNS-760704-CL201 only)
• 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)

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 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

Full record on ClinicalTrials.gov

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