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

Sponsored by:	ProEthic Pharmaceuticals
Information provided by:	ProEthic Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00330850

Purpose

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	Intervention	Phase
Migraine Photophobia Phonophobia	Drug: PRO-513	Phase III

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

Drug Information available for: Diclofenac Diclofenac potassium Diclofenac sodium Proline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by ProEthic Pharmaceuticals:

Estimated Enrollment:	650
Study Start Date:	May 2006
Estimated Study Completion Date:	December 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330850

Locations

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
Houston Headache Clinic
Houston, Texas, United States, 77004
J&S Studies, Inc.
Bryan, Texas, United States, 77802
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

Principal Investigator:

Richard Lipton, MD

Montefiore Headache Center

More Information

Study ID Numbers:	PRO-513301
Study First Received:	May 26, 2006
Last Updated:	March 30, 2007
ClinicalTrials.gov Identifier:	NCT00330850
Health Authority:	United States: Food and Drug Administration

Keywords provided by ProEthic Pharmaceuticals:

Migraine
Photophobia
Phonophobia
Aura

Study placed in the following topic categories:

Sensation Disorders
Otorhinolaryngologic Diseases
Vision Disorders
Eye Diseases
Diclofenac
Central Nervous System Diseases
Headache Disorders, Primary
Photophobia
Brain Diseases

Ear Diseases
Headache Disorders
Signs and Symptoms
Hearing Disorders
Migraine Disorders
Headache
Neurologic Manifestations
Hyperacusis

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009