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

ProEthic Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Photophobia; Migraine; Phonophobia

Treatments: Drug: PRO-513

Study type: Interventional

Funder types: Industry

Identifiers

NCT00330850

PRO-513301

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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