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Safety and Efficacy Study of NP001 in Patients With Amyotrophic Lateral Sclerosis (ALS) and Systemic Inflammation | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS) and Evidence of Elevated Systemic Inflammation

NCT02794857•Neuraltus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

21 - 80 years

Sex

ALL

Healthy Volunteers

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

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

Locations (22)

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

Key Dates

Start Date

August 29, 2016

Primary Completion Date

December 12, 2017

Completion Date

December 12, 2017

Last Updated

May 7, 2018

Enrollment

138

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis

Interventions

NP001

DRUG

Placebo

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 7, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS

Intermuscular Coherence as a Biomarker for ALS

Connect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI)

UPenn Observational Research Repository on Neurodegenerative Disease

Control Cohort CTRL COH

Identifying Biomarkers in ALS Patients Using Neuronal Derived Extracellular Vesicles