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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frovatriptan | Experimental | 5.0 mg of Frovatriptan given as single dose |
|
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Frovatriptan | Drug | Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast |
|
| 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 |
| 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 |
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Inclusion Criteria:
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Stephen D. Silberstein, M.D. | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jefferson Headache Center | Philadelphia | Pennsylvania | 19107 | United States |
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Eligible participants were recruited from our office practice or surrounding community from 7/16/07 through 3/18/09
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| ID | Title | Description |
|---|---|---|
| FG000 | Frovatriptan | 5.0 mg of Frovatriptan given as single dose |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Frovatriptan | 5.0 mg of Frovatriptan given as single dose |
| BG001 | Placebo | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 20 hours |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Frovatriptan | 5.0 mg of Frovatriptan given as single dose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Nausea (may be secondary to study medication or associated symptom of migraine) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen D. Silberstein, M.D. | Jefferson Headache Center/Thomas Jefferson University | 215-955-2243 | stephen.silberstein@jefferson.edu |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C108128 | frovatriptan |
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| Placebo | Drug | Inert tab identical in appearance to Frovatriptan |
|
| Onset of headache within 4 hours of fast |
|
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Time to Development of Headache of Any Intensity | Time to development of headache of any intensity in the 2 treatment arms | Posted | Mean | 95% Confidence Interval | hours | 20 hours |
|
|
|
|
| 0 |
| 35 |
| 1 |
| 35 |
| EG001 | Placebo | 0 | 36 | 5 | 36 |
|
| sleepiness/fatigue | General disorders |
|
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| D009422 | Nervous System Diseases |