Frovatriptan as preemptive treatment for fasting-induced migraine.
OBJECTIVE
To examine frovatriptan's efficacy as preemptive treatment for fasting-induced migraine.


BACKGROUND
Fasting is a common migraine trigger that cannot always be avoided. The development of a short-term preemptive approach would be of benefit. Because of its longer half-life, frovatriptan has been effectively used for short-term daily use to prevent menstrually related migraines and might prove useful in the prevention of fasting-induced migraine.


METHODS
This was a double-blind, placebo-controlled, randomized, parallel-group trial.


METHODS
With a history of fasting-induced episodic migraine were randomly assigned to receive either frovatriptan (5.0 mg) or placebo (ratio 1:1).


METHODS
Took a single dose of study medication at the start of their 20-hour fast. Information about headache intensity, associated symptoms, and use of rescue medication was captured at defined time points from the start of the fast through 20 hours post-fast.


RESULTS
Of the 75 subjects screened, 74 subjects were randomized and 71 subjects completed the study. Demographic characteristics of the placebo and frovatriptan treatment groups were not statistically different. Thirty-three subjects received active drug. Twelve (36.4%) developed a headache between 6 and 20 hours after the start of the fast (1/33 mild, 11/33 moderate or severe). In the placebo group, 18/34 (52.9%) developed a headache (4/34 mild, 14/34 moderate or severe). The difference between the 2 treatment groups did not achieve statistical significance; Pearson chi-square, P = .172. Kaplan-Meier survival analysis showed no difference between the 2 treatment groups with respect to the time of onset of headache of any intensity (log rank, P = .264) and for the time of onset of a moderate or severe intensity (log rank, P = .634).


CONCLUSIONS
More subjects on placebo developed a headache than those on frovatriptan. Perhaps because of the small number of subjects involved, the differences in headache incidences observed did not achieve statistical significance.
From the Thomas Jefferson University-Neurology/Headache, Jefferson Headache Center, Philadelphia, PA, USA (M. Latsko and S. Silberstein); Albert Einstein University-Neurology/Headache, New York, NY, USA (N. Rosen).
Meryl
M
Latsko
From the Thomas Jefferson University-Neurology/Headache, Jefferson Headache Center, Philadelphia, PA, USA (M. Latsko and S. Silberstein); Albert Einstein University-Neurology/Headache, New York, NY, USA (N. Rosen).
Stephen
S
Silberstein
From the Thomas Jefferson University-Neurology/Headache, Jefferson Headache Center, Philadelphia, PA, USA (M. Latsko and S. Silberstein); Albert Einstein University-Neurology/Headache, New York, NY, USA (N. Rosen).
Noah
N
Rosen
D000328:Adult; D002227:Carbazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005215:Fasting / Q000009:adverse effects*; D005260:Female; D006207:Half-Life; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000453:epidemiology / Q000209:etiology* / Q000517:prevention & control*; D010865:Pilot Projects; D017366:Serotonin Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014363:Tryptamines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
D002227:Carbazoles; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C108128:frovatriptan