Back to resultsA Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting
Primary Purpose
Migraine
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Frovatriptan
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility 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
Sites / Locations
- Jefferson Headache Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Frovatriptan
placebo
Arm Description
5.0 mg of Frovatriptan given as single dose
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Time to Development of Headache of Any Intensity
Time to development of headache of any intensity in the 2 treatment arms
Full Information
NCT ID
NCT00440232
First Posted
February 22, 2007
Last Updated
May 23, 2011
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT00440232
Brief Title
A Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting
Official Title
A Pilot Trial Examining the Safety and Efficacy of Frovatriptan as a Preemptive Treatment for Fasting-Induced Migraine Headache
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Thomas Jefferson University
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Frovatriptan
Arm Type
Experimental
Arm Description
5.0 mg of Frovatriptan given as single dose
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Frovatriptan
Other Intervention Name(s)
Frova
Intervention Description
Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inert tab identical in appearance to Frovatriptan
Primary Outcome Measure Information:
Title
Incidence of Fasting-induced Headache of Any Intensity
Description
Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting
Time Frame
20 hours
Secondary Outcome Measure Information:
Title
Time to Development of Headache of Any Intensity
Description
Time to development of headache of any intensity in the 2 treatment arms
Time Frame
20 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen D. Silberstein, M.D.
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jefferson Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
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A Research Study To Evaluate If Frovatriptan Is Safe And Effective In Preventing Migraine Headache After Fasting
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