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Clinical Trial
. 2016 May;36(6):503-9.
doi: 10.1177/0333102415597891. Epub 2015 Jul 31.

Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache

Daniel Fossum Bratbak  1 , Ståle Nordgård  2 , Lars Jacob Stovner  3 , Mattias Linde  4 , Mari Folvik  5 , Vegard Bugten  2 , Erling Tronvik  4
Affiliations
Clinical Trial

Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache

Daniel Fossum Bratbak et al. Cephalalgia. 2016 May.

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.

Method: 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.

Conclusion: Randomised, placebo-controlled studies are warranted to establish the potential of this possible novel treatment of cluster headache.

Keywords: Cluster headache; botulinum toxin; headache; pterygopalatine ganglion; sphenopalatine ganglion.

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Figures

Figure 1.
Figure 1.
Main efficacy measure. Mean cluster attack frequency per week for baseline and after one single BTA treatment of SPG, intention-to-treat analysis (n = 9). BTA: onabotulinumtoxinA; SPG: sphenopalatine ganglion.
Figure 2.
Figure 2.
Number of attacks by intensity. Attacks graded mild or moderate and severe or unbearable. Per protocol participants (n = 7).
See this image and copyright information in PMC

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