Study 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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
NP001, Placebo
Placebo:
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Gil Block, MD, PhD, Neuraltus Pharmaceuticals, Inc., Robert G. Miller, MD, California Pacific Medical Center, Jonathan Katz, MD, California Pacific Medical Center
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
Neuraltus
United States
Full Study Summary:
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.
Study Sponsor:
Neuraltus Pharmaceuticals, Inc.
Estimated Enrollment:
138
Estimated Study Start Date:
08 / 29 / 2016
Estimated Study Completion Date:
12 / 12 / 2017
Posting Last Modified Date:
05 / 07 / 2018
Date Study Added to neals.org:
06 / 09 / 2016
Primary Outcome Measures:
Change from baseline in score on ALS Functional Rating Scale-Revised (ALSFRS-R) questionnaire [ Time Frame: Baseline and 6 months ]
Secondary Outcome Measures:
Change in pulmonary function as measured by slow vital capacity readings [ Time Frame: Baseline and 6 months ]
Time to tracheotomy [ Time Frame: Up to 6 months ]
Change in levels of blood inflammatory biomarkers [ Time Frame: Baseline, 3 and 6 months ]
Minimum Age:
21 Years
Maximum Age:
80 Years
Can participants use Riluzole?
Yes
Key Inclusion Criteria:- Diagnosis of clinically possible, clinically probable (with or without laboratory support), or clinically definite ALS (using the revised El Escorial 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
Key Exclusion Criteria:
- Life expectancy of less than 6 months
- 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
St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Phoenix, Arizona
85013
United States
Mayo Clinic Arizona
Scottsdale, Arizona
85259
United States
Cedars-Sinai Medical Center
Los Angeles, California
90048
United States
University of California, Irvine, Department of Neurology
Orange, California
92862
United States
Forbes Norris MDA/ALS Research Center, CPMC
San Francisco, California
94115
United States
Mayo Clinic Florida
Jacksonville, Florida
32224
United States
University of Miami Miller School of Medicine
Miami, Florida
33136
United States
Emory University, Department of Neurology
Atlanta, Georgia
30322
United States
University of Kansas Medical Center
Kansas City, Kansas
66160
United States
University of Kentucky, Albert B. Chandler Medical Center
Lexington, Kentucky
40536-0293
United States
Massachusetts General Hospital
Boston, Massachusetts
02114
United States
Clinical & Translational Science Institute, University of Minnesota
Minneapolis, Minnesota
55414
United States
Washington University School of Medicine
Saint Louis, Missouri
63110
United States
Columbia University Medical Center
New York, New York
10032
United States
Carolinas Medical Center, Neurosciences Instutite-Neurology
Charlotte, North Carolina
28207
United States
Duke Neurological Disorders Clinic at Morreene Road
Durham, North Carolina
27705
United States
Cleveland Clinic Foundation-Cleveland Clinic Hospital
Cleveland, Ohio
44195
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio
43210
United States
Providence Brain & Spine Institute, ALS Center
Portland, Oregon
97213
United States
Houston Methodist Neurological Institute
Houston, Texas
77030
United States
University of Texas Health Sciences Center San Antonio
San Antonio, Texas
78229
United States
Montreal Neurological Institute
Montreal, Quebec
H3A 2B4
Canada