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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Knopp Biosciences
ClinicalTrials.gov Identifier:
NCT00931944
First received: June 30, 2009
Last updated: May 27, 2014
Last verified: May 2014
  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.


Condition Intervention Phase
Amyotrophic Lateral Sclerosis
Drug: KNS-760704
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Safety and Tolerability, Study Evaluating KNS-760704 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Resource links provided by NLM:


Further study details as provided by Knopp Biosciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: July 2009
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931944

Locations
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
St. 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
Investigators
Principal Investigator: Merit Cudkowicz, M.D., MSc NeuroClinical Trials Unit (Massachusetts General Hospital)
  More Information

Additional Information:
No publications provided

Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT00931944     History of Changes
Other Study ID Numbers: KNS-760704-CL211
Study First Received: June 30, 2009
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Knopp Biosciences:
ALS
Amyotrophic Lateral Sclerosis
Lou Gehrig
Lou Gehrig's
Lou Gehrig's disease
Motor Neuron Disease
Nervous System Diseases
KNS-760704
RTPB

Additional relevant MeSH terms:
Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on October 02, 2014