Study Purpose:
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.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):
Robert G. Miller, MD, Forbes Norris ALS Treatment and Research, California Pacific Medical Center
Clinicaltrials.gov ID:
Neals Affiliated?
No
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:
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.
Study Sponsor:
Neuraltus Pharmaceuticals, Inc.
Estimated Enrollment:
136
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
Minimum Age:
21 Years
Maximum Age:
80 Years
Can participants use Riluzole?
Yes
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:Inclusion Criteria:
- 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.
Mayo Clinic, Scottsdale
Scottsdale, Arizona
85259
United States
UC, Irvine
Irvine, California
92868-4281
United States
UCLA
Los Angeles, California
90095
United States
California Pacific Med Center Forbes Norris MDA/ALS Research and Treatment Center
San Francisco, California
94115
United States
Mayo Clinic, Jacksonville
Jacksonville, Florida
32224
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The Emory Clinic
Atlanta, Georgia
30322
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Kansas City, Kansas
66160
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Lexington, Kentucky
40536-0284
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02129
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New York, New York
10032
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SUNY Upstate Medical University, Syracuse
Syracuse, New York
13210
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Charlotte, North Carolina
28207
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Duke University, Dept of Neurology
Durham, North Carolina
27705
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Cleveland Clinic
Cleveland, Ohio
44195
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Providence ALS Center
Portland, Oregon
97213
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Methodist Hospital Research Institute, Methodist Neurologic Institute
Houston, Texas
77030
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Providence Saint Peter Hospital
Centralia, Washington
98531
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