title: Two center, randomized pilot study of migraine prophylaxis comparing paradigms using pre-emptive frovatriptan or daily topiramate: research and clinical implications.
abstract: OBJECTIVE
  To compare the efficacy and clinical benefit of 2 paradigms of migraine prevention using pre-emptive frovatriptan and daily topiramate. The study compares the paradigms of pre-emptive use of frovatriptan, a drug approved for acute migraine, and the daily use of topiramate, a Federal Drug Administration-approved and -accepted standard for migraine prophylaxis.
  
  
  BACKGROUND
  Traditionally, preventive treatment of migraine required daily medication. However, recent studies suggest that pre-emptive prophylaxis may be beneficial to those migraineurs who can predict an attack of migraine based on premonitory symptoms and treat during that phase.
  
  
  METHODS
  A total of 76 adult subjects with a diagnosis of migraine were screened for the study. During a 1-month baseline period, subjects demonstrated through a daily diary that they predicted at least 50% of migraine attacks during the premonitory phase and treated with their usual medication. Of these, 55 were randomized to either Group A (daily topiramate) or Group B (frovatriptan during premonitory symptoms); 44 completed the study. The treatment period lasted 2 months. The subjects answered the Migraine-Specific Quality of Life Questionnaire at randomization, and at Weeks 4 and 8. The revised Patient Perception of Migraine Questionnaire was answered 24 hours after taking frovatriptan (Group A, for break-through headaches; Group B, treatment during premonitory symptoms).
  
  
  RESULTS
  The number of migraine attacks and headache days per month decreased significantly from baseline for both Groups A and B. Subjects in Group A had considerably more adverse events leading to study withdrawal than in Group B (18% vs 4%). Though this study was not powered to directly compare the efficacy of the 2 drugs, topiramate showed superiority over frovatriptan at Month 2 in reduction of headache days, which was a secondary end point in the study (P = .036).
  
  
  CONCLUSIONS
  This pilot study demonstrated that statistical benefit for reduction of headache days over baseline for both pre-emptive frovatriptan and daily topiramate. Subjects utilizing pre-emptive frovatriptan experienced fewer adverse events leading to study withdrawal. Subjects utilizing daily topiramate had fewer headache days at Month 2.
authors.affiliation: Headache Care Center, 3805 S. Kansas Expressway, Springfield, MO 65807, USA. rcady@banyangroupinc.com
authors.forename: Roger K
authors.initials: RK
authors.lastname: Cady
authors.forename: James
authors.initials: J
authors.lastname: Voirin
authors.forename: Kathleen
authors.initials: K
authors.lastname: Farmer
authors.forename: Rebecca
authors.initials: R
authors.lastname: Browning
authors.forename: M E
authors.initials: ME
authors.lastname: Beach
authors.forename: Jeanne
authors.initials: J
authors.lastname: Tarrasch
mesh_terms: D000293:Adolescent; D000328:Adult; D002227:Carbazoles / Q000008:administration & dosage* / Q000191:economics; D003365:Costs and Cost Analysis; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005632:Fructose / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000191:economics; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000191:economics / Q000517:prevention & control* / Q000523:psychology; D018696:Neuroprotective Agents / Q000008:administration & dosage* / Q000191:economics; D058748:Pain Perception / Q000187:drug effects; D017060:Patient Satisfaction; D010865:Pilot Projects; D011788:Quality of Life; D017366:Serotonin Receptor Agonists / Q000191:economics; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D013997:Time Factors; D000077236:Topiramate; D016896:Treatment Outcome; D014363:Tryptamines / Q000008:administration & dosage* / Q000191:economics; D055815:Young Adult
chemical_list: D002227:Carbazoles; D018696:Neuroprotective Agents; D017366:Serotonin Receptor Agonists; D014363:Tryptamines; D000077236:Topiramate; D005632:Fructose; C108128:frovatriptan