title: Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache.
abstract: OBJECTIVE
  The main object of this pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in intractable chronic cluster headache. Efficacy data were also collected to provide indication on whether future placebo-controlled studies should be performed.
  
  
  METHODS
  In a prospective, open-label, uncontrolled study, we performed a single injection of 25 IU (n = 5) or 50 IU BTA (n = 5) towards the SPG in 10 patients with intractable chronic cluster headache with a follow-up of 24 weeks. The primary outcome was adverse events (AEs) and the main efficacy outcome was attack frequency in weeks 3 and 4 post-treatment.
  
  
  RESULTS
  A total of 11 AEs were registered. There was one severe adverse event (SAE): posterior epistaxis. The number of cluster headache attacks (main efficacy outcome) was statistically significantly reduced in the intention-to-treat analysis from 18 ± 12 per week in baseline to 11 ± 14 (p = 0.038) in weeks 3 and 4, and five out of 10 patients had at least 50% reduction of attack frequency compared to baseline. The cluster attack frequency was significantly reduced for five out of six months post-treatment.
  
  
  CONCLUSIONS
  Randomised, placebo-controlled studies are warranted to establish the potential of this possible novel treatment of cluster headache.
authors.affiliation: Department of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Norway Department of Neuroscience, Norwegian University of Science and Technology, Norway daniel.f.bratbak@ntnu.no.
authors.forename: Daniel Fossum
authors.initials: DF
authors.lastname: Bratbak
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Department of ENT, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Ståle
authors.initials: S
authors.lastname: Nordgård
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Lars Jacob
authors.initials: LJ
authors.lastname: Stovner
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olavs Hospital, Trondheim University Hospital, Norway Department of Neurology, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Mattias
authors.initials: M
authors.lastname: Linde
authors.affiliation: Department of Radiology, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Mari
authors.initials: M
authors.lastname: Folvik
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Department of ENT, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Vegard
authors.initials: V
authors.lastname: Bugten
authors.affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Norway Norwegian Advisory Unit on Headache, St. Olavs Hospital, Trondheim University Hospital, Norway Department of Neurology, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Erling
authors.initials: E
authors.lastname: Tronvik
mesh_terms: D000328:Adult; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D003027:Cluster Headache / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D038361:Neuronavigation; D010148:Intractable Pain / Q000188:drug therapy*; D010865:Pilot Projects; D011446:Prospective Studies; D059387:Sphenopalatine Ganglion Block / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: Cluster headache; botulinum toxin; headache; pterygopalatine ganglion; sphenopalatine ganglion