CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 74 enrolled
Drug / intervention
Frovatriptan +1 moredrug
Likely dose
Frovatriptan 5.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00440232
NCT00440232N/ACompleted

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

Thomas Jefferson University·interventional·Posted Feb 26, 2007·Updated May 26, 2011

In Brief

A clinical study evaluating Frovatriptan and Placebo for Migraine. Completed, enrolled 74 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMigraine
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 26, 2007
Enrollment StartJul 1, 2007
Primary CompletionMar 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 19.3 years ago

Interventions

Frovatriptandrug

Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast

Placebodrug

Inert tab identical in appearance to Frovatriptan