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

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 Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Frovatriptan; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Jefferson Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects between the ages of 18 and 65, inclusive
• Subjects diagnosed with episodic migraine, with or without aura according to IHS criteria for at least one-year prior to screening
• Subjects who experience between 1 and 6 migraine attacks per month inclusive (during the previous 6 months) with no more than 15 days of headache per month.
• Subject reports hunger or fasting as a known trigger for migraine
• Subject is using or agrees to use for the duration of participation a medically acceptable form of contraception (as determined by investigator), if female of child-bearing potential
• Subjects who are able to understand and comply with all study procedures.
• Subject is willing to complete one 20-hour fast, starting between 5:00 and 8:00 P.M., with no food or drink (except water needed to take routine medication)
• Subject provides written informed consent prior to any screening procedures being conducted
• If subject is taking a preventive migraine medication for migraine or any other reason, that medication must have been a stable dose for at least 4 weeks prior to screening, and must remain stable throughout the duration of the study.

EXCLUSION CRITERIA

• Pregnant and/or lactating women
• Subjects who have a history of clinically relevant allergy to frovatriptan or like compounds
• Subjects who, in the investigators opinion, have a history or have evidence of any other medical or psychiatric condition that would expose them to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and tolerability during this trial
• Subjects who have participated in an investigational drug trial in the 30 days prior to the screening visit
• Subjects who currently have or have a history of significant cerebrovascular disease including basilar or hemiplegic migraine
• Subjects who have a history of non-response to triptans, as determined by investigator
• Subjects with uncontrolled hypertension
• Subjects with diabetes mellitus who require insulin or oral anti-hyperglycemic agents will be excluded. (Subjects with Type II diabetes who are well controlled with diet and exercise alone may be included.)
• Subjects who currently have or who have a history of ischemia and/or vasospastic coronary artery disease
• Subjects who, in the investigators opinion, have significant risk factors of coronary artery disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; Inert tab identical in appearance to Frovatriptan
Experimental: Frovatriptan; 5.0 mg of Frovatriptan given as single dose	Drug: Frovatriptan; Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast; Other Names: Frova

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Fasting-induced Headache of Any Intensity	Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting	20 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Development of Headache of Any Intensity	Time to development of headache of any intensity in the 2 treatment arms	20 hours

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Investigators: Principal Investigator: Stephen D. Silberstein, M.D., Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: February 22, 2007
• First Submitted That Met QC Criteria: February 23, 2007
• First Posted (Estimate): February 26, 2007

Study Record Updates

• Last Update Posted (Estimate): May 26, 2011
• Last Update Submitted That Met QC Criteria: May 23, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Frovatriptan
• Other Study ID Numbers: SDS/FHA-FRV/ 01