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

 -  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 Criteria:

 -  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