An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
Lead SponsorProEthic Pharmaceuticals
StatusCompleted No Results Posted
Indication/ConditionPhotophobia Phonophobia Migraine
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