Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)
This study is ongoing, but not recruiting participants.
Sponsor:
Knopp Neurosciences
Information provided by (Responsible Party):
Knopp Neurosciences
ClinicalTrials.gov Identifier:
NCT00931944
First received: June 30, 2009
Last updated: May 10, 2013
Last verified: May 2013
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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 Neurosciences:
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 ]
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 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:
- 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 Criteria:
- 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)
Contacts and Locations
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 Neurosciences
Investigators
| Principal Investigator: | Merit Cudkowicz, M.D., MSc | NeuroClinical Trials Unit (Massachusetts General Hospital) |
More Information
Additional Information:
No publications provided
| Responsible Party: | Knopp Neurosciences |
| ClinicalTrials.gov Identifier: | NCT00931944 History of Changes |
| Other Study ID Numbers: | KNS-760704-CL211 |
| Study First Received: | June 30, 2009 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Knopp Neurosciences:
|
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:
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes Pramipexol |
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 May 22, 2013