A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine
- Conditions
- Migraine
- Registration Number
- NCT00475514
- Lead Sponsor
- Endo Pharmaceuticals
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 500
- Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Primary endpoint Number of MRM headache free PMPs out of a potential of three treated PMPs
- Secondary Outcome Measures
Name Time Method 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