Almotriptan 12.5 mg in menstrually related migraine: a randomized, double-blind, placebo-controlled study.
BACKGROUND
Menstrually related migraine (MRM) affects more than half of female migraineurs. Because such migraines are often predictable, they provide a suitable target for treatment in the mild pain phase. The present study was designed to provide prospective data on the efficacy of almotriptan for treatment of MRM.


METHODS
Premenopausal women with MRM were randomized to almotriptan (N = 74) or placebo (N = 73), taken at onset of the first perimenstrual migraine. Patients crossed over to the other treatment for the first perimenstrual migraine of their second cycle, followed by a two-month open-label almotriptan treatment period.


RESULTS
Significantly more patients were pain-free at two hours (risk ratio [RR] = 1.81; p = .0008), pain-free from 2-24 hours with no rescue medication (RR = 1.99; p = .0022), and pain-free from 2-24 hours with no rescue medication or adverse events (RR = 1.94; p = .0061) with almotriptan versus placebo. Nausea (p = .0007) and photophobia (p = .0083) at two hours were significantly less frequent with almotriptan. Almotriptan efficacy was consistent between three attacks, with 56.2% of patients pain-free at two hours at least twice. Adverse events were similar with almotriptan and placebo.


CONCLUSIONS
Almotriptan was significantly more effective than placebo in women with MRM attacks, with consistent efficacy in longer-term follow-up.
Allais
Gianni
G
Women's Headache Center, Department of Gynecology and Obstetrics, University of Turin, Italy. gb.allais@tiscali.it
Bussone
Gennaro
G
D'Andrea
Giovanni
G
Moschiano
Franca
F
d'Onofrio
Florindo
F
Valguarnera
Fabio
F
Manzoni
Gian Camillo
GC
Grazzi
Licia
L
Allais
Rita
R
Benedetto
Chiara
C
Acuto
Giancarlo
G
D000293:Adolescent; D000328:Adult; D000818:Animals; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008599:Menstruation Disturbances / Q000188:drug therapy*; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D010919:Placebos; D011446:Prospective Studies; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014363:Tryptamines / Q000008:administration & dosage* / Q000009:adverse effects; D055815:Young Adult
D010919:Placebos; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; C409045:almotriptan