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

This study has been completed.
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00440232
First received: February 22, 2007
Last updated: May 23, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Migraine
Drug: Frovatriptan
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Trial Examining the Safety and Efficacy of Frovatriptan as a Preemptive Treatment for Fasting-Induced Migraine Headache

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Incidence of Fasting-induced Headache of Any Intensity [ Time Frame: 20 hours ] [ Designated as safety issue: No ]
    Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting


Secondary Outcome Measures:
  • Time to Development of Headache of Any Intensity [ Time Frame: 20 hours ] [ Designated as safety issue: No ]
    Time to development of headache of any intensity in the 2 treatment arms


Enrollment: 74
Study Start Date: July 2007
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Frova
Placebo Comparator: placebo Drug: Placebo
Inert tab identical in appearance to Frovatriptan

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440232

Locations
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Stephen D. Silberstein, M.D. Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Stephen D. Silberstein, M.D., Jefferson Headache Center, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00440232     History of Changes
Other Study ID Numbers: SDS/FHA-FRV/ 01
Study First Received: February 22, 2007
Results First Received: October 26, 2010
Last Updated: May 23, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Frovatriptan
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014