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

Completed · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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

Key facts

Study ID

NCT01281631

Run by

Neuraltus Pharmaceuticals, Inc.

People needed

136

Starts

2011-02-01

Expected to finish

2012-09-01

Last updated by the study team

2012-11-22

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• SUNY Upstate Medical University, Syracuse — Syracuse, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Duke University, Dept of Neurology — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Providence ALS Center — Portland, Oregon, United States
• Methodist Hospital Research Institute, Methodist Neurologic Institute — Houston, Texas, United States
• Providence Saint Peter Hospital — Centralia, Washington, United States

Full record on ClinicalTrials.gov

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