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

Completed · Phase 3

Conditions studied: Migraine, Photophobia, Phonophobia

In brief

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.

Key facts

Study ID

NCT00330850

Run by

ProEthic Pharmaceuticals

People needed

650

Starts

2006-05-01

Expected to finish

2006-12-01

Last updated by the study team

2007-04-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Associated Neurologists of Southern CT — Fairfield, Connecticut, United States
• New England Center for Headache — Stamford, Connecticut, United States
• LCFP Inc. — Fort Myers, Florida, United States
• Palm Beach Neurological Center — Palm Beach Gardens, Florida, United States
• Diamond Headache Clinic — Chicago, Illinois, United States
• International Research Center — Towson, Maryland, United States
• Michigan Head-Pain and Neurologic Institute — Ann Arbor, Michigan, United States
• Mercy Health Research — St Louis, Missouri, United States
• New York Headache Center — New York, New York, United States
• Headache Wellness Center — Greensboro, North Carolina, United States
• DermResearch, Inc. — Austin, Texas, United States
• J&S Studies, Inc. — Bryan, Texas, United States
• Houston Headache Clinic — Houston, Texas, United States
• Road Runner Research, Ltd. — San Antonio, Texas, United States
• The Innovative Clinical Research Center — Alexandria, Virginia, United States
• Advanced Healthcare, S.C. — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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