PMID- 32583902 OWN - NLM STAT- MEDLINE DCOM- 20211108 LR - 20211108 IS - 1526-4610 (Electronic) IS - 0017-8748 (Linking) VI - 60 IP - 8 DP - 2020 Sep TI - Open-Label, Multi-Dose, Pilot Safety Study of Injection of OnabotulinumtoxinA Toward the Otic Ganglion for the Treatment of Intractable Chronic Cluster Headache. PG - 1632-1643 LID - 10.1111/head.13889 [doi] AB - BACKGROUND: The otic ganglion (OG) provides parasympathetic innervation to the cerebral circulation and cranial structures and may be involved in the pathophysiology of trigeminal autonomic headaches. This structure has never been targeted in any headache disorder. OBJECTIVE: To investigate the safety of injecting onabotulinumtoxin A (BTA) toward the OG in 10 patients with intractable chronic cluster headache and to collect efficacy data. METHODS: A total of 10 patients with chronic cluster headache were enrolled in this open-label, multi-dose pilot safety study. All patients were recruited and treated on an out-patient basis at St Olav's University Hospital (Norway). In 5 patients each, the OG was the injection target with 12.5 IU of BTA or 25 IU, respectively. The primary outcome measure was adverse events (AEs) and the main secondary outcome was the number of attacks per week measured at baseline and in the second month following injection. RESULTS: For the primary endpoint, we analyzed data for all 10 patients. There were a total of 17 AEs in 6 of the 10 patients. All AEs were considered mild and disappeared by the end of follow-up. The median number of attacks per week at baseline was 17.0 [7.8 to 25.8] vs 14.0 [7.3 to 20.0] in the second month following injection; difference: 3 (95%CI: -0.3 to 7.9), P = .063. CONCLUSIONS: Injection with BTA toward the OG appears to be safe. We did not find a statistically significant reduction in the number of attacks per week at month 2 after injection compared to the baseline. This study suggests that the OG is not an important target for the treatment of chronic cluster headache. A future study employing more precise targeting of the OG may be indicated. CI - (c) 2020 The Authors. Headache: The Journal of Head and Face Pain published by Wiley Periodicals LLC on behalf of American Headache Society. FAU - Crespi, Joan AU - Crespi J AD - Department of Neurology, St. Olav's University Hospital, Trondheim, Norway. AD - Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway. FAU - Bratbak, Daniel AU - Bratbak D AD - Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway. AD - Department of Neurosurgery, St. Olav's University Hospital, Trondheim, Norway. FAU - Dodick, David W AU - Dodick DW AD - Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway. AD - Department of Neurology, Mayo Clinic, Phoenix, AZ, USA. FAU - Matharu, Manjit AU - Matharu M AD - UCL Queen Square Institute of Neurology, The National Hospital of Neurology and Neurosurgery, London, UK. FAU - Solheim, Ole AU - Solheim O AD - Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway. AD - Department of Neurosurgery, St. Olav's University Hospital, Trondheim, Norway. FAU - Gulati, Sasha AU - Gulati S AD - Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway. AD - Department of Neurosurgery, St. Olav's University Hospital, Trondheim, Norway. FAU - Berntsen, Erik Magnus AU - Berntsen EM AD - Department of Radiology and Nuclear Medicine, St. Olav's University Hospital, Trondheim, Norway. AD - Department of Circulation and Medical Imaging, Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Norway. FAU - Tronvik, Erling AU - Tronvik E AD - Department of Neurology, St. Olav's University Hospital, Trondheim, Norway. AD - Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway. LA - eng GR - 46056923/NTNU (Norwegian University of Science and Technology) and "The Liaison Committee for Education, Research and Innovation in Central Norway" (Samarbeidsorganet)/ PT - Clinical Trial PT - Journal Article DEP - 20200625 PL - United States TA - Headache JT - Headache JID - 2985091R RN - 0 (Neuromuscular Agents) RN - EC 3.4.24.69 (Botulinum Toxins, Type A) RN - EC 3.4.24.69 (onabotulinum toxin A) SB - IM MH - Adult MH - Aged MH - Botulinum Toxins, Type A/administration & dosage/adverse effects/*pharmacology MH - Chronic Disease MH - Cluster Headache/*drug therapy MH - *Drug-Related Side Effects and Adverse Reactions MH - Female MH - Ganglia, Parasympathetic/*drug effects MH - Humans MH - Injections MH - Male MH - Middle Aged MH - Neuromuscular Agents/administration & dosage/adverse effects/*pharmacology MH - Outcome Assessment, Health Care MH - Pilot Projects OTO - NOTNLM OT - botulinum toxin OT - chronic cluster headache OT - otic ganglion OT - pterygopalatine ganglion OT - sphenopalatine ganglion OT - trigeminal autonomic cephalalgia EDAT- 2020/06/26 06:00 MHDA- 2021/11/09 06:00 CRDT- 2020/06/26 06:00 PHST- 2020/01/06 00:00 [received] PHST- 2020/05/18 00:00 [revised] PHST- 2020/05/18 00:00 [accepted] PHST- 2020/06/26 06:00 [pubmed] PHST- 2021/11/09 06:00 [medline] PHST- 2020/06/26 06:00 [entrez] AID - 10.1111/head.13889 [doi] PST - ppublish SO - Headache. 2020 Sep;60(8):1632-1643. doi: 10.1111/head.13889. Epub 2020 Jun 25.