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

Abstract

ObjectiveThe 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.MethodIn 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.ResultsA 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.ConclusionRandomised, placebo-controlled studies are warranted to establish the potential of this possible novel treatment of cluster headache.

Treatment of Cluster Headache: The American Headache Society Evidence‐Based Guidelines

“…Other therapies with reports of efficacy in the treatment of CH that did not satisfy the inclusion criteria for our systematic review have been either recommended by other guidelines, discussed as therapeutic options in expert opinions, or reported in case series or open label studies . Such treatments include methysergide, methylergonovine, flunarizine, topiramate, gabapentin, baclofen, clonidine, pizotifen, histamine sulfate, kudzu, 2‐bromo lysergic acid diethylamide, hormonal therapies such as testosterone and clomiphene, as well as interventional therapies such as botulinum toxin injections, sphenopalatine ganglion blockade, and radiofrequency ablation.…”

The Sphenopalatine Ganglion: Anatomy, Pathophysiology, and Therapeutic Targeting in Headache

“…Most recently, an open‐label pilot study assessed the efficacy and safety of a single injection of 25‐50 units of onabotulinumtoxinA administered to the PPF under general anesthesia with preoperative imaging guidance in 10 patients using either a transnasal (n = 9) or percutaneous infrazygomatic (n = 1) approach in 10 patients with intractable chronic CH . In the intention to treat analysis, CH attack frequency at weeks 3 and 4 were reduced to 11 ± 14 from 18 ± 12 per week at baseline ( P = .038).…”

Long‐Term Outcome of Patients With Intractable Chronic Cluster Headache Treated With Injection of Onabotulinum Toxin A Toward the Sphenopalatine Ganglion – An Observational Study

“…) was used to perform the injection. In this pilot study, a significant reduction (≥50%) in CH attack frequency was observed in 5 out of 7 per‐protocol (PP) patients . After the pilot study, patients experiencing recurring attacks had access to repeated injections with minimal intervals of 3 months using the lateral injection technique (Fig.…”

“…The sphenopalatine ganglion (SPG) is a large extracranial parasympathetic ganglion located in the pterygopalatine fossa and is thought to play a key role in CH pathogenesis . In a prospective, open‐label pilot study, our research group (Bratbak et al) performed blockade of the SPG with 25 to 50 IU onabotulinumtoxin type A (BTA) in 10 patients with CCH . The treatment was performed with a transnasal technique in 9 out of 10 subjects; in one subject a percutaneous infrazygomatic (lateral) approach was preferred due to anatomical anomalies.…”