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An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330850
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : April 2, 2007
Sponsor:
Information provided by:
ProEthic Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Photophobia Phonophobia Drug: PRO-513 Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 650 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Study Start Date : May 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330850


Locations
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United States, Connecticut
Associated Neurologists of Southern CT
Fairfield, Connecticut, United States, 06824
New England Center for Headache
Stamford, Connecticut, United States, 06902
United States, Florida
LCFP Inc.
Ft. Myers, Florida, United States, 33907
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States, 33410
United States, Illinois
Diamond Headache Clinic
Chicago, Illinois, United States, 60614
United States, Maryland
International Research Center
Towson, Maryland, United States, 21286
United States, Michigan
Michigan Head-Pain and Neurologic Institute
Ann Arbor, Michigan, United States, 48104
United States, Missouri
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, New York
New York Headache Center
New York, New York, United States, 10021
United States, North Carolina
Headache Wellness Center
Greensboro, North Carolina, United States, 27401
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J&S Studies, Inc.
Bryan, Texas, United States, 77802
Houston Headache Clinic
Houston, Texas, United States, 77004
Road Runner Research, Ltd.
San Antonio, Texas, United States, 78258
United States, Virginia
The Innovative Clinical Research Center
Alexandria, Virginia, United States, 22304
United States, Wisconsin
Advanced Healthcare, S.C.
Milwaukee, Wisconsin, United States, 53209
Sponsors and Collaborators
ProEthic Pharmaceuticals
Investigators
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Principal Investigator: Richard Lipton, MD Montefiore Headache Center
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ClinicalTrials.gov Identifier: NCT00330850    
Other Study ID Numbers: PRO-513301
First Posted: May 29, 2006    Key Record Dates
Last Update Posted: April 2, 2007
Last Verified: March 2007
Keywords provided by ProEthic Pharmaceuticals:
Migraine
Photophobia
Phonophobia
Aura
Additional relevant MeSH terms:
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Hyperacusis
Migraine Disorders
Photophobia
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action