Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation

Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation

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:
Neuraltus
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
>65
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
<36 months
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
no
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
no
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Unknown

Update Notes:

5/3/2018Trial complete
7/17/2017Recruitment status updated
3/23/2017Location updated
2/24/2017Neuraltus put out press release stating trial is 50% enrolled.
2/13/2017No significant updates
1/10/2017Location updated
11/28/2016Location updated
11/3/2016Location updated
8/30/2016Trial information added to database

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

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):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 5/24/2016
ClinicalTrials.gov ID: NCT02794857
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov