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

Study Overview
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Brief Summary
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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
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See above

Official Title
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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

Conditions
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Migraine

Intervention / Treatment
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* Drug: Frovatriptan 2.5mg QD
* Drug: Frovatriptan 2.5 mg BID
* Drug: placebo


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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Frovatriptan 2.5mg QD|nan|
|Drug: Frovatriptan 2.5 mg BID|nan|
|Drug: placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menstrually-related Migraine Headache, 'Difficult to Treat' as specified in protocol