Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine

Abstract

ObjectiveThe 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.MethodIn 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.ResultsAll 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.ConclusionThe result warrants randomised, placebo-controlled studies to establish both safety and efficacy of this potential novel treatment of chronic migraine.

Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia

“…The AEs of the technique used in this study appears to offer a favorable AE profile with mostly mild and transient AEs and with no severe AEs reported. These results are similar to earlier reports by our group in 2 other pilot trials …”

“…The estimated duration of the injection is around 3 minutes, and for the whole procedure including navigation system setup 20‐30 minutes. In this study, we used the same injection technique as in pilot trials in intractable chronic cluster headache and intractable chronic migraine …”

“…Results are given as median and range. Means (±SD) were calculated in order to produce comparable results to other studies targeting the SPG using the same technique …”

“…Parasympathetic fibers synapse in the SPG using acetylcholine as neurotransmitter . onabotulinumtoxinA (BTA) blocks the release of acetylcholine and 2 pilot trials have examined the safety of injections of BTA toward the SPG in patients with intractable chronic cluster headache and intractable chronic migraine …”

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

“…There were no serious adverse events (SAE) registered. The same injection technique was also used in a small study with 10 patients with intractable chronic migraine (study performed by our research group) who received bilateral injections . The procedure was well accepted also by these patients, and the AEs registered were classified as mild and resolved within 1–12 weeks.…”