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Sponsored by: |
ProEthic Pharmaceuticals |
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Information provided by: | ProEthic Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00330850 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Richard Lipton, MD | Montefiore Headache Center |
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 |
Migraine Photophobia Phonophobia Aura |
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 |
Nervous System Diseases |