title: Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine.
abstract: Objective The main objective of this pilot study was to investigate the safety of administering onabotulinumtoxinA towards the sphenopalatine ganglion in 10 patients with intractable chronic migraine with an open, uncontrolled design. We also collected efficacy data to provide an indication as to whether future placebo-controlled studies should be performed. Method In a prospective, open-label, uncontrolled study after one-month baseline, we performed bilateral injections of 25 IU onabotulinumtoxinA (total dose 50 IU) toward the sphenopalatine ganglion in a single outpatient session in 10 patients with intractable migraine with a follow-up of 12 weeks. The primary outcome was adverse events and the main efficacy outcome was frequency of moderate and severe headache days in month 2 post-treatment compared to baseline. Results All 10 patients experienced a total of 25 adverse events. The majority of these were different types of local discomfort in the face and jaw, and none were classified as serious. In an intention-to-treat analysis of the main efficacy outcome, a statistically significant reduction of moderate and severe headache days in baseline versus month 2 was observed (16.3 ± 6.2 days baseline versus 7.6 ± 7.6 days month 2, p = 0.009). Eight out of 10 patients experienced an at least 50% reduction of moderate and severe headache days compared to baseline. Conclusion The result warrants randomised, placebo-controlled studies to establish both safety and efficacy of this potential novel treatment of chronic migraine.
authors.affiliation: 1 Department of Neurosurgery, St. Olavs Hospital, Trondheim University Hospital, Norway.|2 Department of Neuroscience, NTNU Norwegian University of Science and Technology, Norway.
authors.forename: Daniel Fossum
authors.initials: DF
authors.lastname: Bratbak
authors.affiliation: 2 Department of Neuroscience, NTNU Norwegian University of Science and Technology, Norway.|3 Department of ENT, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Ståle
authors.initials: S
authors.lastname: Nordgård
authors.affiliation: 2 Department of Neuroscience, NTNU Norwegian University of Science and Technology, Norway.|4 Norwegian Advisory Unit on Headaches, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Lars Jacob
authors.initials: LJ
authors.lastname: Stovner
authors.affiliation: 2 Department of Neuroscience, NTNU Norwegian University of Science and Technology, Norway.|4 Norwegian Advisory Unit on Headaches, St. Olavs Hospital, Trondheim University Hospital, Norway.|5 Department of Neurology, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Mattias
authors.initials: M
authors.lastname: Linde
authors.affiliation: 2 Department of Neuroscience, NTNU Norwegian University of Science and Technology, Norway.|6 Department of Neurology, Mayo Clinic, USA.
authors.forename: David W
authors.initials: DW
authors.lastname: Dodick
authors.affiliation: 2 Department of Neuroscience, NTNU Norwegian University of Science and Technology, Norway.
authors.forename: Irina
authors.initials: I
authors.lastname: Aschehoug
authors.affiliation: 7 Department of Radiology, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Mari
authors.initials: M
authors.lastname: Folvik
authors.affiliation: 2 Department of Neuroscience, NTNU Norwegian University of Science and Technology, Norway.|4 Norwegian Advisory Unit on Headaches, St. Olavs Hospital, Trondheim University Hospital, Norway.|5 Department of Neurology, St. Olavs Hospital, Trondheim University Hospital, Norway.
authors.forename: Erling
authors.initials: E
authors.lastname: Tronvik
mesh_terms: D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage* / Q000009:adverse effects; D059350:Chronic Pain / Q000188:drug therapy; D005260:Female; D005726:Ganglia, Parasympathetic / Q000187:drug effects; D006801:Humans; D007267:Injections / Q000295:instrumentation / Q000379:methods; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D009465:Neuromuscular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D010865:Pilot Projects; D056739:Pterygopalatine Fossa / Q000187:drug effects; D055815:Young Adult
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: Chronic migraine; botulinum toxin; headache; pterygopalatine ganglion; sphenopalatine ganglion