Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies.
These are the first prospective studies to use criteria for menstrual migraine proposed in the 2004 revision of the International Classification of Headache Disorders (ICHD-II) to examine the efficacy of rizatriptan for treatment of a menstrual attack. Two identical protocols (MM1 and MM2) were randomized, parallel, placebo-controlled, double-blind studies. Adult women with ICHD-II menstrual migraine were assigned to either rizatriptan 10-mg tablet or placebo in a 2 : 1 ratio. Patients treated a single menstrual migraine attack of moderate or severe pain intensity. The primary end-point was 2-h pain relief and the secondary end-point was 24-h sustained pain relief. A total of 707 patients (MM1 357, MM2 350) treated a menstrual migraine attack. The percentage of patients reporting 2-h pain relief was significantly greater for rizatriptan than for placebo (MM1 70% vs. 53%, MM2 73% vs. 50%), as was the percentage of patients reporting 24-h sustained pain relief (MM1 46% vs. 33%; MM2 46% vs. 33%). Rizatriptan 10 mg was effective for the treatment of ICHD-II menstrual migraine, as measured by 2-h pain relief and 24-h sustained pain relief.
Mannix
L K
LK
Headache Associates and ClinExcel Research, West Chester, OH 45069, USA. lkmannixmd@aol.com
Loder
E
E
Nett
R
R
Mueller
L
L
Rodgers
A
A
Hustad
C M
CM
Ramsey
K E
KE
Skobieranda
F
F
D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage; D015897:Comorbidity; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008599:Menstruation Disturbances / Q000188:drug therapy* / Q000453:epidemiology*; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy* / Q000453:epidemiology*; D009820:Ohio / Q000453:epidemiology; D010147:Pain Measurement / Q000187:drug effects*; D015990:Placebo Effect; D017366:Serotonin Receptor Agonists / Q000008:administration & dosage; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage*; D014363:Tryptamines / Q000008:administration & dosage*
D000700:Analgesics; D017366:Serotonin Receptor Agonists; D014230:Triazoles; D014363:Tryptamines; C093622:rizatriptan