drugset / Trial / NCT00475514

A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine

NCT00475514

Phase 3 Completed 500 enrolled Endo USA Inc., a Keenova Therapeutics Company
RandomizedParallel-groupDouble-blind

Summary

Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle. Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.

Timeline

Start
2004-10
Primary completion
2006-03
Completion
2006-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Frovatriptan Small molecule 2.5 mg Oral

Indications