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Quick Info
Status
This study has been completed
Phase
2
Trial Type
Safety/Efficacy
Treatment Type
Intravenous administration (i.v. drip)
Randomization
Unknown
Enrollment
138
Start Date
8/29/2016
Sponsor
Contact Information
Locations
United States, Arizona
St. Joseph's Hospital and Medical Center Barrow Neurology Clinics, Phoenix, AZ, 85013, United States
Mayo Clinic Arizona, Scottsdale, AZ, 85259, United States
United States, California
University of California, Irvine, Department of Ne, Orange, CA, 92862, United States
Forbes Norris MDA/ALS Research Center CPMC, San Francisco, CA, 94115, United States
United States, Florida
Mayo Clinic Florida, Jacksonville, FL, 32224, United States
University of Miami Miller School of Medicine, Miami, FL, 33136, United States
United States, Georgia
Emory University, Department of Neurology, Atlanta, GA, 30322, United States
United States, Kansas
University of Kansas Medical Center, Kansas City, KS, 66160, United States
United States, Kentucky
University of Kentucky Albert B. Chandler Medical Center, Lexington, KY, 40536, United States
United States, Massachusetts
Massachusetts General Hospital, Boston, MA, 02114, United States
United States, Missouri
Washington University School of Medicine, St. Louise, MO, 63110, United States
United States, New York
Columbia University Medical Center, New York, NY, 10032, United States
United States, North Carolina
Carolinas Medical Center, Neurosciences Instutite-, Charlotte, NC, 28207, United States
United States, Ohio
Cleveland Clinic Foundation-Cleveland Clinic Hospi, Cleveland, OH, 44195, United States
The Ohio State University Wexner Medical Center, Columbus, OH, 43210, United States
United States, Oregon
Providence Brain & Spine Institute ALS Center, Portland, OR, 97213, United States
United States, Texas
Houston Methodist Neurological Institute, Houston, TX, 77030, United States
University of Texas Health Sciences Center San Ant, San Antonio, TX, 78229, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
>65
Months Since Onset
Number of months since first symptoms of ALS.
<36 months
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
no
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
no
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Unknown
Open Label
Unknown
Update Notes
Trial complete
5/3/2018
Recruitment status updated
7/17/2017
Location updated
3/23/2017
Neuraltus put out press release stating trial is 50% enrolled.
2/24/2017
No significant updates
2/13/2017
Location updated
1/10/2017
Location updated
11/28/2016
Location updated
11/3/2016
Trial information added to database
8/30/2016

Other Information

Purpose
This study evaluates NP001 in patients with amyotrophic lateral sclerosis (ALS) and evidence of systemic inflammation. Half of participants will receive NP001 and the other half will receive placebo.
Eligibility
Details
This is a randomized, double-blind, placebo-controlled study of NP001 in subjects with ALS and evidence of elevated systemic inflammation. Subjects will be allocated (1:1) to NP001 and placebo. Drug or placebo will be given intravenously.
Collaborator(s)
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Trial Protocol as Published on Clinicaltrials.gov
NCT02794857 (First Published: 5/24/2016)