Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation
NCT ID: NCT02794857
Last Updated: 2018-05-07
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
138 participants
INTERVENTIONAL
2016-08-29
2017-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NP001
NP001 2 mg/kg by intravenous administration for 5 consecutive days in Month 1 and for 3 consecutive days in Months 2 through 6
NP001
Placebo
Normal saline by intravenous administration for 5 consecutive days in Month 1 and for 3 consecutive days in Months 2 through 6
Placebo
Interventions
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NP001
Placebo
Eligibility Criteria
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Inclusion Criteria
* Forced vital capacity greater than or equal to 65% of that predicted for age and height
* Onset of ALS-related weakness less than 3 years prior to first dose of study drug
* Plasma high sensitivity C-reactive protein (hs-CRP) concentration of greater than or equal to 0.113 mg/dL at pre-screening/screening
* Stable dose (greater than 30 days) 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
* Tracheotomy or be using ventilatory assistance, including Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)
* Active pulmonary disease
* Gastrostomy
* Stem cell therapy
* Immune modulator therapy or participation in studies of other agents within 12 weeks of pre-screening/screening
* Unstable medical condition other than ALS
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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Gil Block, MD, PhD
Role: STUDY_DIRECTOR
Neuraltus Pharmaceuticals, Inc.
Robert G. Miller, MD
Role: PRINCIPAL_INVESTIGATOR
California Pacific Medical Center
Jonathan Katz, MD
Role: PRINCIPAL_INVESTIGATOR
California Pacific Medical Center
Locations
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St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Phoenix, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Irvine, Department of Neurology
Orange, California, United States
Forbes Norris MDA/ALS Research Center, CPMC
San Francisco, California, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Emory University, Department of Neurology
Atlanta, Georgia, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky, Albert B. Chandler Medical Center
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Clinical & Translational Science Institute, University of Minnesota
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Columbia University Medical Center
New York, New York, United States
Carolinas Medical Center, Neurosciences Instutite-Neurology
Charlotte, North Carolina, United States
Duke Neurological Disorders Clinic at Morreene Road
Durham, North Carolina, United States
Cleveland Clinic Foundation-Cleveland Clinic Hospital
Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Providence Brain & Spine Institute, ALS Center
Portland, Oregon, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
University of Texas Health Sciences Center San Antonio
San Antonio, Texas, United States
Montreal Neurological Institute
Montreal, Quebec, Canada
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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NP001-10-003
Identifier Type: -
Identifier Source: org_study_id
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