- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00330850
An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
March 30, 2007 updated by: ProEthic Pharmaceuticals
The purpose of the study is to show the efficacy of a single dose of PRO-513 for treating subjects suffering moderate pain form a migraine attack, with or without aura.
The study is also intended to show the effectiveness of PRO-513 for associated symptoms of nausea, photophobia, and phonophobia due to a migraine attack.
Study Overview
Study Type
Interventional
Enrollment
650
Phase
- Phase 3
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
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Connecticut
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Fairfield, Connecticut, United States, 06824
- Associated Neurologists of Southern CT
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Stamford, Connecticut, United States, 06902
- New England Center for Headache
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Florida
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Ft. Myers, Florida, United States, 33907
- LCFP Inc.
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Palm Beach Gardens, Florida, United States, 33410
- Palm Beach Neurological Center
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Illinois
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Chicago, Illinois, United States, 60614
- Diamond Headache Clinic
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Maryland
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Towson, Maryland, United States, 21286
- International Research Center
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Michigan
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Ann Arbor, Michigan, United States, 48104
- Michigan Head-Pain and Neurologic Institute
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Missouri
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St. Louis, Missouri, United States, 63141
- Mercy Health Research
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New York
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New York, New York, United States, 10021
- New York Headache Center
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North Carolina
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Greensboro, North Carolina, United States, 27401
- Headache Wellness Center
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Texas
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Austin, Texas, United States, 78759
- Dermresearch, Inc.
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Bryan, Texas, United States, 77802
- J&S Studies, Inc.
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Houston, Texas, United States, 77004
- Houston Headache Clinic
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San Antonio, Texas, United States, 78258
- Road Runner Research, Ltd.
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Virginia
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Alexandria, Virginia, United States, 22304
- The Innovative Clinical Research Center
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Wisconsin
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Milwaukee, Wisconsin, United States, 53209
- Advanced Healthcare, S.C.
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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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male and Female subjects
- 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
- Listing of additional inclusion criteria are available through the Sponsor
Exclusion Criteria:
- Excluding subjects with a history of other serious events causing secondary headaches
- 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
- Listing of additional exclusion criteria are available through the Sponsor
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
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Richard Lipton, MD, Montefiore Headache 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
May 1, 2006
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
May 26, 2006
First Submitted That Met QC Criteria
May 26, 2006
First Posted (Estimate)
May 29, 2006
Study Record Updates
Last Update Posted (Estimate)
April 2, 2007
Last Update Submitted That Met QC Criteria
March 30, 2007
Last Verified
March 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO-513301
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.
Clinical Trials on Migraine
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Tonix Pharmaceuticals, Inc.PremierCompletedChronic Migraine | Chronic Migraine, Headache | Chronic Migraine Without Aura | Aura MigraineUnited States
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Harvard University Faculty of MedicineBrigham and Women's Hospital; Palmer Center for Chiropractic Research (PCCR)CompletedMigraine | Migraine Disorders | Migraine Without Aura | Migraine With Aura | Migraine, ClassicUnited States
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University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
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University of FlorenceAzienda Ospedaliera Città della Salute e della Scienza di Torino; University... and other collaboratorsRecruitingMigraine | Chronic Migraine | Migraine Without Aura | Migraine With AuraItaly
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Notre-Dame Hospital, Montreal, Quebec, CanadaAllerganCompletedChronic Migraine | Migraine Without Aura | Migraine With AuraCanada
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Glostrup University Hospital, CopenhagenUnknownChronic Migraine | Migraine Without Aura | Migraine With AuraDenmark
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
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The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
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