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Quick Info
Status
This study has been completed
Estimated Enrollment
138
Phase
2
Treatment Type
Intravenous administration (i.v. drip)
Trial Type
Safety/Efficacy
Sponsor
Primary Investigator
Frances Faurot
Contact Information
Locations
University of Kansas Medical Center, Kansas City, 66160
Providence Brain & Spine Institute ALS Center, Portland, 97213
St. Joseph's Hospital and Medical Center Barrow Neurology Clinics, Phoenix, 85013
Mayo Clinic Arizona, Scottsdale, 85259
Forbes Norris MDA/ALS Research Center CPMC, San Francisco, 94115
University of California, Irvine, Department of Ne, Orange, 92862
Mayo Clinic Florida, Jacksonville, 32224
University of Miami Miller School of Medicine, Miami, 33136
University of Kentucky Albert B. Chandler Medical Center, Lexington, 40536
Massachusetts General Hospital, Boston, 02114
Carolinas Medical Center, Neurosciences Instutite-, Charlotte, 28207
Houston Methodist Neurological Institute, Houston, 77030
Emory University, Department of Neurology, Atlanta, 30322
Cleveland Clinic Foundation-Cleveland Clinic Hospi, Cleveland, 44195
Columbia University Medical Center, New York, 10032
The Ohio State University Wexner Medical Center, Columbus, 43210
Washington University School of Medicine, St. Louise, 63110
University of Texas Health Sciences Center San Ant, San Antonio, 78229
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
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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News Articles and Summaries
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ALS Forum
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Trial Protocol as Published on Clinicaltrials.gov
NCT02794857 (First Published: 5/24/2016)