Safety and Efficacy of NPS 1776 in the Acute Treatment of Migraine Headaches
NCT ID: NCT00172094
Last Updated: 2021-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
189 participants
INTERVENTIONAL
2003-12-31
2004-07-31
Brief Summary
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Detailed Description
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Many antiepileptic drugs (AEDs) have demonstrated efficacy as acute and/or prophylaxis therapy for migraine, even though the mechanism of action of the various AEDs is poorly understood.
NPS 1776, isovaleramide, is a neutral aliphatic amide. The mechanism by which NPS 1776 exerts its therapeutic actions in nonclinical animal models of disease is unclear. The same is true for many antiepileptics on the market today. NPS 1776 does not appear to bind directly to various CNS receptor centers, although it shows a broad range of anticonvulsant activity in multiple animal models of seizures. This broad profile of anticonvulsant activity is similar to that of valproic acid (VPA), and may also predict NPS 1776 efficacy in the treatment of migraine.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
PLACEBO
PLACEBO
Placebo in non-carbonated fruit flavored drink (150 ml)
2
400 mg 1776 powder
NPS 1776 (400 mg)
NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink
3
1776 (800 mg)
NPS 1776 (800 mg)
NPS 1776 (800 mg) powder
Interventions
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NPS 1776 (800 mg)
NPS 1776 (800 mg) powder
PLACEBO
Placebo in non-carbonated fruit flavored drink (150 ml)
NPS 1776 (400 mg)
NPS1776 in powdered form to be mixed with a non-carbonated fruit flavored drink
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Experiences 2-10 migraine headaches per month (with at least 24 hours between episodes) and no more than 15 headache days per month in the 3 months prior to screening.
3. Ability and willingness to arrive at the investigator's center within 1 hour (±5 min) of migraine pain onset (defined as pain that is consistent with the subject's usual migraine and is of at least moderate severity).
4. Ability and willingness to abstain from taking medications not allowed by the protocol and to meet phone and check-in criteria.
5. Ability and willingness to undergo a comprehensive urine toxicology screen for both licit and illicit drugs.
6. Ability and willingness to complete a migraine-history diary from screening to treatment with study drug and a migraine-treatment diary from discharge through the remainder of the 24-hour period following study-drug treatment.
Exclusion Criteria
2. Severe or acute cardiovascular or cerebrovascular disease, uncontrolled hypertension, or basilar or hemiplegic migraines.
3. History of hypersensitivity, allergies, or nonresponse to valproic acid.
4. Have taken VPA or other AED in the 30 days prior to screening, or are taking a migraine prophylaxis treatment other than a stable dose of propranolol or tricyclic antidepressant.
5. Migraine attacks that in the investigator's opinion are associated with intractable nausea and/or vomiting.
6. Any acute or chronic condition that in the investigator's opinion would limit the subject's ability to complete and/or participate in this clinical study or would place the subject at increased risk.
7. Have newly started or changed the dose of either feverfew or magnesium (above 200 mg, the amount in common daily supplements) within 3 months prior to screening.
18 Years
60 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Medical Affiliated Research Center
Huntsville, Alabama, United States
Clinical Study Centers, LLC
Little Rock, Arkansas, United States
North County Neurological Associates
Oceanside, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Clinical Innovations
Santa Ana, California, United States
California Medical Clinic for Headache
Santa Monica, California, United States
The New England Center for Headache
Stamford, Connecticut, United States
University Clinical Research, Inc
Pembroke Pines, Florida, United States
Diamond Headache Clinic
Chicago, Illinois, United States
MedTrial Boston
Wellesley Hills, Massachusetts, United States
Michigan Head-Pain & Neurological Institute
Ann Arbor, Michigan, United States
Mercy Health Research
Chesterfield, Missouri, United States
Headache Care Center/ Clinvest
Springfield, Missouri, United States
University of Medicine and Dentistry, New Jersey School of Osteopathic Medicine
Moorestown, New Jersey, United States
Neuroscience Center of Northern New Jersey
Morristown, New Jersey, United States
Headache Wellness Center
Greensboro, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Neurology Ctr. of Ohio
Toledo, Ohio, United States
The Neurology Clinic
Portland, Oregon, United States
Thomas Jefferson University Hospital/ Jefferson Headache Center
Philadelphia, Pennsylvania, United States
Houston Headache Clinic
Houston, Texas, United States
Neurology & Neurosurgery Associates of Tacoma, Inc., PS
Tacoma, Washington, United States
Countries
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Related Links
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American Headache Society - Site dedicated to the study and treatment of headaches of all types including but not limited to migraines.
Other Identifiers
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CL1776-005
Identifier Type: -
Identifier Source: org_study_id
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