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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ProEthic Pharmaceuticals
• Treatments: Diclofenac

Criteria

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