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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475514
• Other study ID #: VML 251-3MRM02
• Status: Completed
• Phase: Phase 3
• Start date: October 2004
• Est. completion date: March 2006

Study information

• Verified date: December 2023
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

See above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Frovatriptan 2.5mg QD

• Frovatriptan 2.5 mg BID

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs
Secondary	Incidence of MRM headache
Secondary	Maximum headache intensity
Secondary	Incidence of moderate or severe MRM headaches
Secondary	Number of MRM headache free days during treated PMPs
Secondary	Incidence of MRM headache associated symptoms (e.g. photophobia, phonophobia, nausea and vomiting)
Secondary	Functional impairment during treatment phase
Secondary	Time to onset (days) of MRM headache (during the treated PMP and until five days post treatment)
Secondary	Time to onset of first post-treatment migraine Incidence of intercurrent migraine outside of the peri-menstrual period Use of rescue medication