Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Aug;44(8):3331024241273967.
doi: 10.1177/03331024241273967.

Open label experience of repeated OnabotulinumtoxinA injections towards the sphenopalatine ganglion in patients with chronic cluster headache and chronic migraine

Lucy Simmonds  1   2 , Kent Are Jamtøy  3   4 , Irina Aschehoug  3 , Sozaburo Hara  3   5 , Tore W Meisingset  3   6   7 , Manjit S Matharu  1   2   6 , Erling Tronvik  3   6   7 , Daniel Fossum Bratbak  3   5
Affiliations
Free article

Open label experience of repeated OnabotulinumtoxinA injections towards the sphenopalatine ganglion in patients with chronic cluster headache and chronic migraine

Lucy Simmonds et al. Cephalalgia. 2024 Aug.
Free article

Abstract

Background: A novel technique for injection of OnabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) has shown promise in refractory chronic migraine (CM) and chronic cluster headache (CCH). Open label safety and efficacy data are presented here.

Methods: Patients with refractory CM or CCH who had received at least one injection and completed headache diaries were included. Efficacy was defined as ≥50% reduction in moderate-to-severe headache days for CM, or ≥50% reduction in attack frequency for CCH, at weeks five to eight.

Results: Over 261 injections, there were 123 adverse events (AE), of which one was serious. Most (93%) AEs were mild and all were transient. The 50% response to one injection was 81% for CM and 69% for CCH. The response gradually reduced over subsequent months for CM but stayed between 55% and 67% for CCH. Repeated injections were beneficial.

Conclusions: Injections resulted in improvement for both groups and was maintained with repeated injections. Repeat injection after three months may be beneficial in CM. Adverse events were not uncommon, but universally transient, presumably as a result of the mechanism of action of BTA. Repeated BTA injection towards the SPG could be an effective treatment for refractory CM and CCH. Larger, randomised, placebo-controlled trials are required.

Keywords: botulinum toxin type a; refractory cluster headache; refractory headache; refractory migraine.

PubMed Disclaimer

Conflict of interest statement

Declaration of conflicting interestsThe authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: SH and KAJ have no conflicts of interest. LS receives research funding from The Wellington Hospital, London, UK. IA has stocks in Keimon Medical. TWM has been an honorary lecturer for Roche, TEVA Norway AS and Lundbeck AS and is a programme committee member for Lilly. He is a shareholder in Vilje Bionics AS and Keimon Medical AS. MSM serves on the advisory board for AbbVie, Abbott, Eli Lilly, Kriya, Lundbeck, Pfizer, Salvia and TEVA and has received payment for the development of educational presentations from AbbVie, Eli Lilly, Lunbeck and TEVA. He has received research grants from Abbott, Ehler's Danlos Society and Medtronic. He holds a patent (WO2018051103A1) on System and method for diagnosing and treating headaches. He is the chair of the medical advisory board of the CSF Leak Association. ET has Intellectual Property Rights for the MultiGuide device that is used in this paper and which is licensed to Man & Science. He is a consultant for and owner of stocks in Man & Science. He has received personal fees for lectures/ advisory boards from Novartis, Eli Lilly, Abbvie, TEVA, Roche, Lundbeck, Pfizer and Biogen, and has stocks and IP in Nordic Brain Tech. He also has stocks in Keimon Medical. He has received non-personal research funding from several sources, including EU, Norwegian Research Council, Dam foundation, KlinBeForsk. Commissioned research (non-personal): Lundbeck, Pfizer. DB may benefit financially from a commercialization of a proposed treatment targeting the SPG and the intervention device used to perform the treatment through intellectual properties rights and has consulted for Man & Science within the past 12 months.

Substances

LinkOut - more resources