NCT00440232

A Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting

A Pilot Trial Examining the Safety and Efficacy of Frovatriptan as a Preemptive Treatment for Fasting-Induced Migraine Headache

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

We are testing the hypothesis that subjects in the treatment group will experience fewer fasting induced headaches as compared to those in the placebo group.In our clinical experience, we estimate that approximately 25% of our headache population experiences fasting-induced migraine or hunger-induced migraine. With a given migraine incidence of 28 million in the United States alone, we estimate that approximately 7 million will experience hunger as a migraine trigger. If an individual has a known migraine trigger, then there are a variety of ways to modify care in order to address that trigger. The simplest is to avoid that trigger or preemptively treat that trigger. Frovatriptan has good evidence for daily use for a short time to help prevent menstrually related migraines. A short course of treatment can often avoid the initiation of the migraine and improve quality of life. Knowing that a longer acting triptan, such as frovatriptan, has demonstrated capability at suppressing headache through a known trigger, suggests the need to study this with fasting induced migraines, as well.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Frovatriptan	Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast
DRUG	Placebo	Inert tab identical in appearance to Frovatriptan

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-03-01
• Completion: 2009-09-01
• First posted: 2007-02-26
• Last updated: 2011-05-26
• Results posted: 2010-11-18

Locations

1 site across 1 country: United States