A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT01281631
Last Updated: 2012-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2011-02-28
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Low dose NP001
Low drug dose
NP001
Low dose of NP001
High dose NP001
High drug dose
NP001
High dose of NP001
Placebo
normal saline
Placebo
normal saline
Interventions
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NP001
Low dose of NP001
NP001
High dose of NP001
Placebo
normal saline
Eligibility Criteria
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Inclusion Criteria
* Forced Vital Capacity (FVC) at least 70% of that predicted for age and height.
* Stable dose of riluzole if undergoing treatment with this agent.
* For females: Not be of childbearing potential or agree to use adequate birth control during the study.
Exclusion Criteria
* Life expectancy of less than 6 months.
* Require life-sustaining interventions for the 6 months following randomization.
* Have a tracheotomy or be using ventilatory assistance \[including Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)\].
* Active pulmonary disease.
* Immune modulator therapy within 12 weeks of study entry or participation in studies of other agents within the last 4 weeks prior to the randomization.
21 Years
80 Years
ALL
No
Sponsors
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Neuraltus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert G. Miller, MD
Role: PRINCIPAL_INVESTIGATOR
Forbes Norris ALS Treatment and Research, California Pacific Medical Center
Locations
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Mayo Clinic, Scottsdale
Scottsdale, Arizona, United States
UC, Irvine
Irvine, California, United States
UCLA
Los Angeles, California, United States
California Pacific Med Center Forbes Norris MDA/ALS Research and Treatment Center
San Francisco, California, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States
The Emory Clinic
Atlanta, Georgia, United States
University of Kansas Medical Center, Landon Center on Aging
Kansas City, Kansas, United States
University of Kentucky, Department of Neurology
Lexington, Kentucky, United States
Massachusetts General Hospital
Charlestown, Massachusetts, United States
Columbia University
New York, New York, United States
SUNY Upstate Medical University, Syracuse
Syracuse, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Duke University, Dept of Neurology
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Providence ALS Center
Portland, Oregon, United States
Methodist Hospital Research Institute, Methodist Neurologic Institute
Houston, Texas, United States
Providence Saint Peter Hospital
Centralia, Washington, United States
Countries
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References
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Forrest BD, Goyal NA, Fleming TR, Bracci PM, Brett NR, Khan Z, Robinson M, Azhir A, McGrath M. The Effectiveness of NP001 on the Long-Term Survival of Patients with Amyotrophic Lateral Sclerosis. Biomedicines. 2024 Oct 16;12(10):2367. doi: 10.3390/biomedicines12102367.
Other Identifiers
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NP001-10-002
Identifier Type: -
Identifier Source: org_study_id