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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00475514

Enrollment

500

Registered

2007-05-21

Start date

2004-10-31

Completion date

2006-03-31

Last updated

2024-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Keywords

Menstrually-related Migraine Headache, 'Difficult to Treat' as specified in protocol

Brief 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.

Detailed description

See above

Interventions

DRUGFrovatriptan 2.5mg QD

DRUGFrovatriptan 2.5 mg BID

DRUGplacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'

Design outcomes

Primary

Measure	Time frame
Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs	—

Secondary

Measure	Time frame
Incidence of MRM headache	—
Incidence of moderate or severe MRM headaches	—
Number of MRM headache free days during treated PMPs	—
Maximum headache intensity	—
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	—
Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026