An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
- Conditions
- MigrainePhotophobiaPhonophobia
- Registration Number
- NCT00330850
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 650
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Mercy Health Research
🇺🇸St. Louis, Missouri, United States
Diamond Headache Clinic
🇺🇸Chicago, Illinois, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States
LCFP Inc.
🇺🇸Ft. Myers, Florida, United States
International Research Center
🇺🇸Towson, Maryland, United States
The Innovative Clinical Research Center
🇺🇸Alexandria, Virginia, United States
Headache Wellness Center
🇺🇸Greensboro, North Carolina, United States
Associated Neurologists of Southern CT
🇺🇸Fairfield, Connecticut, United States
Palm Beach Neurological Center
🇺🇸Palm Beach Gardens, Florida, United States
New York Headache Center
🇺🇸New York, New York, United States
Michigan Head-Pain and Neurologic Institute
🇺🇸Ann Arbor, Michigan, United States
New England Center for Headache
🇺🇸Stamford, Connecticut, United States
Road Runner Research, Ltd.
🇺🇸San Antonio, Texas, United States
J&S Studies, Inc.
🇺🇸Bryan, Texas, United States
Houston Headache Clinic
🇺🇸Houston, Texas, United States
Advanced Healthcare, S.C.
🇺🇸Milwaukee, Wisconsin, United States