Trials / Completed
CompletedNCT00475514
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (actual)
- Sponsor
- Endo Pharmaceuticals · Industry
- Sex
- Female
- Age
- 15 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Frovatriptan 2.5mg QD | |
| DRUG | Frovatriptan 2.5 mg BID | |
| DRUG | placebo |
Timeline
- Start date
- 2004-10-01
- Primary completion
- 2006-03-01
- Completion
- 2006-03-01
- First posted
- 2007-05-21
- Last updated
- 2024-01-02
Source: ClinicalTrials.gov record NCT00475514. Inclusion in this directory is not an endorsement.