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COMPLETEDPHASE2

A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

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

NCT01281631•Neuraltus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.

Detailed Description

This is a randomized, double-blind, placebo-controlled study of NP001 in subjects with ALS conducted in multiple centers. Drug or placebo will be given intravenously. Approximately 105 subjects will be enrolled. Subjects will be allocated (1:1:1) to placebo and 2 dose levels of NP001.

Eligibility

Age

21 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria. A list of key criteria is listed below:
•Onset of symptoms less than 3 years prior to study entry.
•Forced Vital Capacity (FVC) at least 70% of that predicted for age and height.
•Stable dose 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

•Unstable medical condition(s) other than ALS.
•Life expectancy of less than 6 months.
•Require life-sustaining interventions for the 6 months following randomization.
•Have a tracheotomy or be using ventilatory assistance \[including Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)\].
•Active pulmonary disease.
•Immune modulator therapy within 12 weeks of study entry or participation in studies of other agents within the last 4 weeks prior to the randomization.

Locations (17)

Mayo Clinic, Scottsdale

Scottsdale, Arizona, United States

UC, Irvine

Irvine, California, United States

UCLA

Los Angeles, California, United States

California Pacific Med Center Forbes Norris MDA/ALS Research and Treatment Center

San Francisco, California, United States

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

The Emory Clinic

Atlanta, Georgia, United States

University of Kansas Medical Center, Landon Center on Aging

Kansas City, Kansas, United States

University of Kentucky, Department of Neurology

Lexington, Kentucky, United States

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Columbia University

New York, New York, United States

Key Dates

Start Date

February 1, 2011

Primary Completion Date

September 1, 2012

Completion Date

September 1, 2012

Last Updated

November 22, 2012

Enrollment

136

ACTUAL participants

Conditions

Amyotrophic Lateral Sclerosis

Interventions

NP001

DRUG

NP001

DRUG

Placebo

DRUG

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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: November 22, 2012Data 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.

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A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Inclusion Criteria

Exclusion Criteria

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