Migraine, Phonophobia, Photophobia
Conditions
Keywords
Migraine, Photophobia, Phonophobia, Aura
Brief 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.
Interventions
DRUGPRO-513
Sponsors
ProEthic Pharmaceuticals
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed