Status:
COMPLETED
Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)
Lead Sponsor:
Knopp Biosciences
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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-chl...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00931944
Start Date
July 1 2009
End Date
July 1 2013
Last Update
August 16 2021
Active Locations (19)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
UCLA, Dept. of Neurology - Neuromuscular/ALS Research Center
Los Angeles, California, United States, 90095
3
The Forbes Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
4
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136