Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
KNS-760704
Placebo:
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Merit Cudkowicz, M.D., MSc, NeuroClinical Trials Unit (Massachusetts General Hospital)
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
MGH NCRI
149 13th Street, Bldg 149, MGH East
Charlestown, Massachusetts, 02129 United States
Full Study Summary:
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.
Eligible patients received 1 tablet of KNS-760704 (150 mg) every 12 hours (Q12H) (300 mg total daily dose) for up to 180 weeks.
Study Sponsor:
Knopp Biosciences
Participant Duration:
up to 180 weeks
Estimated Enrollment:
74
Estimated Study Start Date:
05 / 31 / 2009
Estimated Study Completion Date:
07 / 01 / 2013
Posting Last Modified Date:
08 / 16 / 2021
Date Study Added to neals.org:
07 / 02 / 2009
Minimum Age:
21 Years
Maximum Age:
80 Years
Can participants use Riluzole?
Yes
Inclusion Criteria:1. Patient has provided signed informed consent for this trial before the commencement of any study-related procedure
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:
1. Patient did not participate in Knopp Protocol KNS-760704-CL201 or patient did not receive RTPB under Research IND #60,948.
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)
University of Arkansas for Medical Sciences
Little Rock, Arkansas
72205
United States
UCLA, Dept. of Neurology - Neuromuscular/ALS Research Center
Los Angeles, California
90095
United States
The Forbes Norris MDA/ALS Research Center
San Francisco, California
94115
United States
University of Miami Miller School of Medicine
Miami, Florida
33136
United States
University of Kansas Medical Center
Kansas City, Kansas
66160
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland
21228
United States
Massachusettes General Hospital
Boston, Massachusetts
02129
United States
Washington University School of Medicine
Saint Louis, Missouri
63110
United States
Bryan LGH Medical Center East
Lincoln, Nebraska
68506
United States
Columbia University, Lou Gehrig MDA/ALS Research Center
New York, New York
10032
United States
SUNY Upstate Medical University
Syracuse, New York
13210
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania
17033
United States
Drexel University College Of Medicine
Philadelphia, Pennsylvania
19102
United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania
15213
United States
Vanderbilt University Medical Center
Nashville, Tennessee
37232
United States
University of Texas Health Sciences Center of San Antonio
San Antonio, Texas
78229
United States
University of Utah
Salt Lake City, Utah
84132
United States
University of Virginia Health System
Charlottesville, Virginia
22908
United States
University of Washington
Seattle, Washington
98195
United States