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A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS) |
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Study Focus:
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS. |
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Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS |
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Study Category:
Drug Trial |
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Study Status:
Closed |
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Study Results:
http://www.alscon...altus_results.php |
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Phase:
Phase II |
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Type:
Interventional Trial
with active agents/drugs & a placebo |
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Funding Source:
Neuraltus Pharmaceuticals, Inc. |
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Study Chair(s)/Principal Investigator(s):
Robert G. Miller, MD (Forbes Norris ALS Treatment and Research, California Pacific Medical Center) |
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Clinicaltrials.gov ID:
NCT01281631 |
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NEALS Affiliated?
No |
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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.
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# of Subjects:
105 |
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Enrollment Start Date:
02/01/2011 |
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Enrollment End Date:
12/01/-0001 |
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Posting Last Modified Date:
11/01/2011 |
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Date Study Added to alscortium.org:
11/03/2011 |
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| Eligibility Criteria |
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Gender:
Male & Female |
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Minimum Age:
21 |
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Maximum Age:
80 |
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Min Vital Capacity (% predicted normal):
70% |
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Time since Symptom Onset:
Less than 36 months |
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Time since Diagnosis:
Not applicable |
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Can participants use Riluzole?
Yes |
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Coordinating Center
Contact Information |
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| Forbes Norris ALS Treatment and Research, California Pacific Medical Center |
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2324 Sacramento Street, Suite 150
San Francisco, California
UNITED STATES |
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Other Eligibility 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:
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.
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Site Contact Information (Please click to show/hide) |
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| Arizona |
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Mayo Clinic, Scottsdale
13400 East Shea Blvd
Scottsdale, Arizona 85259
UNITED STATES |
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| California |
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UC, Irvine
Irvine, California 92868-4281
UNITED STATES |
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UCLA
Los Angeles, California 90095
UNITED STATES | |
| Florida |
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Mayo Clinic, Jacksonville
4500 San Pablo Road
Jacksonville, Florida 32224
UNITED STATES |
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| Georgia |
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The Emory Clinic
1365 Clifton Road, NE
Atlanta, Georgia 30322
UNITED STATES |
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| Kansas |
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University of Kansas Medical Center, Landon Center on Aging
3901 Rainbow Boulevard
Kansas City, Kansas 66160
UNITED STATES |
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| Kentucky |
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University of Kentucky, Department of Neurology
138 Leader Ave
Lexington, Kentucky 40536-0284
UNITED STATES |
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| Massachusetts |
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Massachusetts General Hospital
149 13th St
Charlestown, Massachusetts 02129
UNITED STATES |
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| New York |
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Columbia University
New York, New York 10032
UNITED STATES |
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SUNY Upstate Medical University, Syracuse
750 East Adams St # 343CWB
Syracuse, New York 13210
UNITED STATES | |
| North Carolina |
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Carolinas Medical Center
1010 Edgehill Road North
Charlotte, North Carolina 28207
UNITED STATES |
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Duke University, Dept of Neurology
Durham, North Carolina 27705
UNITED STATES | |
| Ohio |
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Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44195
UNITED STATES |
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| Oregon |
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Providence ALS Center
5050 NE Hoyt St., Suite 315
Portland, Oregon 97213
UNITED STATES |
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| Texas |
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Methodist Hospital Research Institute, Methodist Neurologic Institute
Houston, Texas 77030
UNITED STATES |
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| Washington |
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Providence Saint Peter Hospital
Centralia, Washington 98531
UNITED STATES |
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Familial ALS- ALS cases are inherited from 2 or more family members, affects 5-10% of ALS cases. Sporadic ALS- disease occurs at random with no clearly associated risk factors; most common form of ALS, affects approximately 90-95% ALS cases. Interventional trial- study where exposure, for example a drug, is assigned; used to determine the effectiveness of a treatment or intervention. With drugs and a placebo- One group gets the active treatment, the other gets the placebo. Everything else is held the same between the two groups, so that any difference in their outcome can be attributed to the active treatment. Observational study- study in which patients are observed and where no treatment is given; researcher has no control over the experiment because they are done in a more natural setting than an interventional trial. Trial Phase- objectives are different for each phase of a trial. - Phase I, drug is given to a small number of people to see if it is safe.
- Phase II begins to look at effectiveness of the drug.
- Phase III is considered the definitive test of whether a drug is effective, held at multiple research sites and much larger than the previous phases.
Vital Capacity- the maximum amount of air that can be expelled from the lungs after a maximum drawing of air into the lungs, measured by a spirometer and then scored as a percentage. |
