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

Condition(s) targeted: Migraine

Intervention: Frovatriptan 2.5mg QD (Drug); Frovatriptan 2.5 mg BID (Drug); placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Endo Pharmaceuticals

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.

Official title: A Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy, and Safety of Oral Frovatriptan in the Prevention on Menstrually-Related Migraine (MRM) Headaches in a ‘Difficult to Treat’ Population

Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment

Primary outcome: Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs

Secondary outcome:

Incidence of MRM headache

Maximum headache intensity

Incidence of moderate or severe MRM headaches

Number of MRM headache free days during treated PMPs

Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)

Functional impairment during treatment phase

Time to onset (days) of MRM headache (during the treated PMP and until five days post treatment)

Time to onset of first post-treatment migraine Incidence of intercurrent migraine outside of the peri-menstrual period Use of rescue medication

Detailed description: See above

Minimum age: 15 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that

fit the criteria for ‘difficult to treat’

Starting date: October 2004
Ending date: April 2006
Last updated: May 17, 2007