title: Onabotulinumtoxin-A treatment in Greek patients with chronic migraine.
abstract: BACKGROUND
  Chronic migraine is a disabling condition, with limited treatment options. We conducted an open label, single arm, prospective clinical trial, to assess the efficacy and safety of onabotulinumtoxin-A in Greek patients with chronic migraine. Since recent evidence suggests that a meaningful clinical response may be delayed until after a third onabotulinumtoxin-A administration, we aimed at assessing outcomes at this time point.
  
  
  METHODS
  A total of 119 patients with CM, scheduled to be treated with Onabotulinumtoxin-A (Botox ®) every 3 months, according to the approved indication and standard clinical practice, were prospectively enrolled. Data documenting changes from baseline (T0-trimester before Onabotulinumtoxin-A first administration) to the period after its third administration (T3) in (i) mean number of monthly headache days (ii) migraine severity as expressed by the mean number of days with peak headache intensity of >4/10 in a 0-10 numerical scale, and (iii) mean number of days with use of any acute headache medication, were collected from patients' headache diaries at each visit.
  
  
  RESULTS
  Of the 119 patients, a total of 81 received 3 courses of onabotulinumtoxin-A and were included in the efficacy population. In those 81 patients, there was a significant decrease in mean headache days/month between T0 and T3 (21.3 ± 5.4 vs 7.7 ± 4.8; P < 0.001); a significant decrease in days with peak headache intensity of >4/10 (11.9 ± 5.5 vs 3.7 ± 3.3; P < 0.001) and finally, the change in days using acute headache medications per month between was also significant (16.2 ± 7.8 vs 5.2 ± 4.3; P < 0.001). Adverse events were few and of non- serious nature.
  
  
  CONCLUSIONS
  Our results strongly support the use of onabotulinumtoxin-A for the prophylaxis of CM, as this intervention proved effective, safe and well tolerated in our cohort of Greek patients.
authors.affiliation: Headache Clinic, Mediterraneo Hospital, Glyfada, Greece. mvikelis@headaches.gr.|Glyfada Headache Clinic, 8 Lazaraki Str, Glyfada, 16675, Greece. mvikelis@headaches.gr.|Headache Outpatient Clinic, 1st Department of Neurology, National and Kapodistrian University of Athens, Athens, Greece. mvikelis@headaches.gr.
authors.forename: Michail
authors.initials: M
authors.lastname: Vikelis
authors.affiliation: Neurology Department of the Saint Andrew's State General Hospital of Patras, Patras, Greece.
authors.forename: Andreas A
authors.initials: AA
authors.lastname: Argyriou
authors.affiliation: Department of Neurology, "Geniki Kliniki" Euromedica, Thessaloniki, Greece.
authors.forename: Emmanouil V
authors.initials: EV
authors.lastname: Dermitzakis
authors.affiliation: Corfu Headache Clinic, Corfu, Greece.
authors.forename: Konstantinos C
authors.initials: KC
authors.lastname: Spingos
authors.affiliation: Headache Outpatient Clinic, 1st Department of Neurology, National and Kapodistrian University of Athens, Athens, Greece.
authors.forename: Dimos D
authors.initials: DD
authors.lastname: Mitsikostas
mesh_terms: D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D059350:Chronic Pain / Q000517:prevention & control; D005260:Female; D006115:Greece; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D009465:Neuromuscular Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D017063:Outcome Assessment, Health Care; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: Chronic migraine; Migraine; Onabotulinumtoxin-A; Prevention; Prophylaxis; Treatment