- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01281631
A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
November 20, 2012 updated by: Neuraltus Pharmaceuticals, Inc.
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
136
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic, Scottsdale
-
-
California
-
Irvine, California, United States, 92868-4281
- UC, Irvine
-
Los Angeles, California, United States, 90095
- UCLA
-
San Francisco, California, United States, 94115
- California Pacific Med Center Forbes Norris MDA/ALS Research and Treatment Center
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic, Jacksonville
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- The Emory Clinic
-
-
Kansas
-
Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center, Landon Center on Aging
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536-0284
- University of Kentucky, Department of Neurology
-
-
Massachusetts
-
Charlestown, Massachusetts, United States, 02129
- Massachusetts General Hospital
-
-
New York
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New York, New York, United States, 10032
- Columbia University
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University, Syracuse
-
-
North Carolina
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Charlotte, North Carolina, United States, 28207
- Carolinas Medical Center
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Durham, North Carolina, United States, 27705
- Duke University, Dept of Neurology
-
-
Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
-
-
Oregon
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Portland, Oregon, United States, 97213
- Providence ALS Center
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-
Texas
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Houston, Texas, United States, 77030
- Methodist Hospital Research Institute, Methodist Neurologic Institute
-
-
Washington
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Centralia, Washington, United States, 98531
- Providence Saint Peter Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
normal saline
|
normal saline
|
Experimental: Low dose NP001
Low drug dose
|
Low dose of NP001
High dose of NP001
|
Experimental: High dose NP001
High drug dose
|
Low dose of NP001
High dose of NP001
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the effects of NP001 on measures of clinical function
Time Frame: over 9 months
|
over 9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability in ALS
Time Frame: duration of study
|
duration of study
|
Pulmonary function and biomarkers
Time Frame: over 9 months
|
over 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert G. Miller, MD, Forbes Norris ALS Treatment and Research, California Pacific Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
September 1, 2012
Study Completion (Actual)
September 1, 2012
Study Registration Dates
First Submitted
January 17, 2011
First Submitted That Met QC Criteria
January 21, 2011
First Posted (Estimate)
January 24, 2011
Study Record Updates
Last Update Posted (Estimate)
November 22, 2012
Last Update Submitted That Met QC Criteria
November 20, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP001-10-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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