Status:
COMPLETED
An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
Lead Sponsor:
ProEthic Pharmaceuticals
Conditions:
Migraine
Photophobia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00330850
Start Date
May 1 2006
End Date
December 1 2006
Last Update
April 2 2007
Active Locations (16)
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1
Associated Neurologists of Southern CT
Fairfield, Connecticut, United States, 06824
2
New England Center for Headache
Stamford, Connecticut, United States, 06902
3
LCFP Inc.
Fort Myers, Florida, United States, 33907
4
Palm Beach Neurological Center
Palm Beach Gardens, Florida, United States, 33410