Study Purpose:This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.
Amyotrophic Lateral Sclerosis
Type of Intervention:
Study Chair(s)/Principal Investigator(s):
Robert G. Miller, MD, Forbes Norris ALS Treatment and Research, California Pacific Medical Center
Coordinating Center Contact Information
Forbes Norris ALS Treatment and Research, California Pacific Medical Center
2324 Sacramento Street, Suite 150
San Francisco, California, United States
Full Study Summary:
Neuraltus Pharmaceuticals, Inc.
Estimated Study Start Date:
01 / 31 / 2011
Estimated Study Completion Date:
09 / 01 / 2012
Posting Last Modified Date:
11 / 22 / 2012
Date Study Added to neals.org:
01 / 24 / 2011
Can participants use Riluzole?
YesSubjects 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.
- 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.
Mayo Clinic, Scottsdale
Los Angeles, California
California Pacific Med Center Forbes Norris MDA/ALS Research and Treatment Center
San Francisco, California
Mayo Clinic, Jacksonville
The Emory Clinic
University of Kansas Medical Center, Landon Center on Aging
Kansas City, Kansas
University of Kentucky, Department of Neurology
Massachusetts General Hospital
New York, New York
SUNY Upstate Medical University, Syracuse
Syracuse, New York
Carolinas Medical Center
Charlotte, North Carolina
Duke University, Dept of Neurology
Durham, North Carolina
Providence ALS Center
Methodist Hospital Research Institute, Methodist Neurologic Institute
Providence Saint Peter Hospital