Trial | NCT00330850  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    650
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.
Study Started
May 31
2006
Study Completion
Dec 31
2006
Last Update
Apr 02
2007
Estimate

Drug PRO-513

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
No Results Posted