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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO-513 | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Lipton, MD | Montefiore Headache Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Associated Neurologists of Southern CT | Fairfield | Connecticut | 06824 | United States | ||
| New England Center for Headache |
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| Stamford |
| Connecticut |
| 06902 |
| United States |
| LCFP Inc. | Fort Myers | Florida | 33907 | United States |
| Palm Beach Neurological Center | Palm Beach Gardens | Florida | 33410 | United States |
| Diamond Headache Clinic | Chicago | Illinois | 60614 | United States |
| International Research Center | Towson | Maryland | 21286 | United States |
| Michigan Head-Pain and Neurologic Institute | Ann Arbor | Michigan | 48104 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| New York Headache Center | New York | New York | 10021 | United States |
| Headache Wellness Center | Greensboro | North Carolina | 27401 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| J&S Studies, Inc. | Bryan | Texas | 77802 | United States |
| Houston Headache Clinic | Houston | Texas | 77004 | United States |
| Road Runner Research, Ltd. | San Antonio | Texas | 78258 | United States |
| The Innovative Clinical Research Center | Alexandria | Virginia | 22304 | United States |
| Advanced Healthcare, S.C. | Milwaukee | Wisconsin | 53209 | United States |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D020795 | Photophobia |
| D012001 | Hyperacusis |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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