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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00931944
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : December 15, 2017
Information provided by (Responsible Party):
Knopp Biosciences

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.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Drug: KNS-760704 Phase 2

Detailed Description:

Patients who complete the Part 2 Week 28 visit in study KNS-760704-CL201 and patients with ALS who are actively receiving RTPB [(6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydro-chloride monohydrate] under Research IND #60,948 may be eligible to participate in this study.

Eligible patients will receive 1 tablet of KNS-760704 150 mg every 12 hours (Q12H) (300 mg total daily dose) for up to 180 weeks.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Safety and Tolerability, Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Study Start Date : July 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: KNS-760704 300 mg/day
Open-label KNS-760704 (150 mg Q12H)
Drug: KNS-760704
150 mg Q12H KNS-760704 given orally (300 mg total daily dose)

Primary Outcome Measures :
  1. The primary objective of the study is to extend the evaluation of long-term safety and tolerability of KNS-760704 300 mg daily. [ Time Frame: 180 weeks ]

Secondary Outcome Measures :
  1. The secondary objective of the study is to evaluate the long-term effects of KNS-760704 300 mg daily on measures of clinical function. [ Time Frame: 180 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00931944

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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
UCLA, Dept. of Neurology - Neuromuscular/ALS Research Center
Los Angeles, California, United States, 90095
The Forbes Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
United States, Florida
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21228
United States, Massachusetts
Massachusettes General Hospital
Boston, Massachusetts, United States, 02129
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Bryan LGH Medical Center East
Lincoln, Nebraska, United States, 68506
United States, New York
Columbia University, Lou Gehrig MDA/ALS Research Center
New York, New York, United States, 10032
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Drexel University College Of Medicine
Philadelphia, Pennsylvania, United States, 19102
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
University of Texas Health Sciences Center of San Antonio
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Knopp Biosciences
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Principal Investigator: Merit Cudkowicz, M.D., MSc NeuroClinical Trials Unit (Massachusetts General Hospital)

Additional Information:
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Responsible Party: Knopp Biosciences Identifier: NCT00931944     History of Changes
Other Study ID Numbers: KNS-760704-CL211
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: November 2017
Keywords provided by Knopp Biosciences:
Amyotrophic Lateral Sclerosis
Lou Gehrig
Lou Gehrig's
Lou Gehrig's disease
Motor Neuron Disease
Nervous System Diseases
Additional relevant MeSH terms:
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Amyotrophic Lateral Sclerosis
Motor Neuron Disease
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents