An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
NCT ID: NCT00330850
Last Updated: 2007-04-02
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
PHASE3
650 participants
INTERVENTIONAL
2006-05-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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PRO-513
Eligibility Criteria
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Inclusion Criteria
* 18-65 years of age
* Primary diagnosis of migraine attack with aura or migraine attack without aura
* Migraine history of averaging at least 1 migraine attack per month but averaging not more than 6 migraine attacks per month over the prior year
* Female subjects must use an effective form of birth control
Exclusion Criteria
* Excluding subjects with a current medical condition that could interfere with the overall study intent or affect the absorption, distribution, metabolism, or excretion of the study medication
* Excluding subjects with a history or current medical condition that could confound the study results or use of a concomitant medication that could interfere with the study drug
18 Years
65 Years
ALL
No
Sponsors
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ProEthic Pharmaceuticals
INDUSTRY
Principal Investigators
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Richard Lipton, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Headache Center
Locations
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Associated Neurologists of Southern CT
Fairfield, Connecticut, United States
New England Center for Headache
Stamford, Connecticut, United States
LCFP Inc.
Fort Myers, Florida, United States
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States
Diamond Headache Clinic
Chicago, Illinois, United States
International Research Center
Towson, Maryland, United States
Michigan Head-Pain and Neurologic Institute
Ann Arbor, Michigan, United States
Mercy Health Research
St Louis, Missouri, United States
New York Headache Center
New York, New York, United States
Headache Wellness Center
Greensboro, North Carolina, United States
DermResearch, Inc.
Austin, Texas, United States
J&S Studies, Inc.
Bryan, Texas, United States
Houston Headache Clinic
Houston, Texas, United States
Road Runner Research, Ltd.
San Antonio, Texas, United States
The Innovative Clinical Research Center
Alexandria, Virginia, United States
Advanced Healthcare, S.C.
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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PRO-513301
Identifier Type: -
Identifier Source: org_study_id