Migraine
Conditions
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.
Interventions
DRUGFrovatriptan
Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast
DRUGPlacebo
Inert tab identical in appearance to Frovatriptan
Sponsors
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Fasting-induced Headache of Any Intensity | 20 hours | Incidence of fasting-induced headache of any intensity occurring at greater than 4 hours, but within 20 hours after onset of fasting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Development of Headache of Any Intensity | 20 hours | Time to development of headache of any intensity in the 2 treatment arms |
Countries
United States
Participant flow
Recruitment details
Eligible participants were recruited from our office practice or surrounding community from 7/16/07 through 3/18/09
Participants by arm
| Arm | Count |
|---|---|
| Frovatriptan 5.0 mg of Frovatriptan given as single dose | 36 |
| Placebo | 38 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Onset of headache within 4 hours of fast | 2 | 2 |
| Overall Study | Unable to treat within allowed time | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Frovatriptan | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 36 Participants | 74 Participants |
| Age Continuous | 38.7 years STANDARD_DEVIATION 12.7 | 40.15 years STANDARD_DEVIATION 11.8 | 39.49 years STANDARD_DEVIATION 12.3 |
| Region of Enrollment United States | 38 participants | 36 participants | 74 participants |
| Sex: Female, Male Female | 30 Participants | 28 Participants | 58 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 35 | 5 / 36 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 |
Outcome results
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
Time frame: 20 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Frovatriptan | Incidence of Fasting-induced Headache of Any Intensity | 12 participants |
| Placebo | Incidence of Fasting-induced Headache of Any Intensity | 18 participants |
p-value: 0.17295% CI: [0.74, 5.235]Chi-squared
Secondary
Time to Development of Headache of Any Intensity
Time to development of headache of any intensity in the 2 treatment arms
Time frame: 20 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Frovatriptan | Time to Development of Headache of Any Intensity | 17.388 hours |
| Placebo | Time to Development of Headache of Any Intensity | 17.06 hours |
p-value: 0.264Log Rank