title: Randomized, placebo-controlled comparison of early use of frovatriptan in a migraine attack versus dosing after the headache has become moderate or severe.
abstract: OBJECTIVE
  To evaluate whether frovatriptan would provide greater relief if given early during a migraine attack.
  
  
  METHODS
  Adults with a history of migraine of at least 1 year, and who had 2-8 headaches in the previous month were recruited from 19 US centres for a prospective, placebo-controlled crossover study over 2 migraine attacks. Dose 1 was taken at the onset of mild migraine headache, Dose 2 was taken at least 2 h later if the headache progressed to moderate/severe. Patients were randomized to receive Dose 1 frovatriptan then Dose 2 placebo or Dose 1 placebo followed by Dose 2 frovatriptan. Treatment order was reversed for the second attack. This schedule enabled a comparison of frovatriptan with placebo and a comparison of early and later treatment with frovatriptan.
  
  
  METHODS
  Freedom from pain at 2 h for frovatriptan versus placebo as Dose 1; use of Dose 2 and/or rescue medication, pain severity, functional impairment and headache recurrence.
  
  
  RESULTS
  In 241 patients who each treated 2 migraine attacks, Dose 1 frovatriptan was more effective than placebo in terms of the proportion of patients who were pain free at 2 h (28% vs 20%, p = 0.04). This benefit was sustained up to 4 h post-dose (p = 0.003). Early use of frovatriptan significantly reduced re-medication (p < 0.001). Twenty-four-hour headache recurrence was low in both early (4%) and later use (6%) groups. Sustained pain-free response occurred in 40% of frovatriptan early use patients compared with 31% of later use patients (p < 0.05). Early use prevented headache progression: 69%-78% had mild/no headache 2-4 h after Dose 1 frovatriptan compared with 54%-63% taking Dose 1 placebo (p < 0.001). Early use reduced pain burden and functional disability (p < or = 0.001). More patients rated early use of frovatriptan as excellent or good (57% vs 46%).
  
  
  CONCLUSIONS
  Early use of frovatriptan resulted in a higher, earlier and sustained pain-free response, prevented progression to moderate/severe headache and reduced pain burden and functional disability.
authors.affiliation: Headache Care Center, Primary Care Network, Inc., Springfield, MO, USA. rcady@primarycarenet.org
authors.forename: Roger
authors.initials: R
authors.lastname: Cady
authors.forename: Arthur
authors.initials: A
authors.lastname: Elkind
authors.forename: Jerome
authors.initials: J
authors.lastname: Goldstein
authors.forename: Charlotte
authors.initials: C
authors.lastname: Keywood
mesh_terms: D000328:Adult; D002227:Carbazoles / Q000008:administration & dosage* / Q000009:adverse effects; D018592:Cross-Over Studies; D018450:Disease Progression; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D012008:Recurrence; D014363:Tryptamines
chemical_list: D002227:Carbazoles; D014363:Tryptamines; C108128:frovatriptan