Botulinum Toxin Type A Block of the Otic Ganglion in Chronic Cluster Headache: Safety Issues
Status:
Completed
Trial end date:
2019-09-13
Target enrollment:
Participant gender:
Summary
Cluster headache (CH) is the most common of the trigeminal autonomic cephalalgias and one of
the most severe pains known to man, having a large impact on the sufferer's quality of life.
A parasympathetic dysfunction in CH has been suggested. The sphenopalatine ganglion has been
a target for treatment of primary headache disorders for more than a century but there are
several anatomic and physiologic studies that suggest that another cranial parasympathetic
ganglion, the otic ganglion (OG), might be also relevant in CH. In this study OG will be
blocked with botulinum toxin type A in a pilot study in 10 patients with chronic cluster
headache. Recruitment of patients will be solely in Norway. There is no data available to
determine the correct dosage of botulinum toxin. A similar neural structure that has been
blocked with botulinum toxin in humans is the sphenopalatine ganglion. The investigators
injected 10 patients suffering from intractable chronic cluster headache with botulinum toxin
in the sphenopalatine ganglion. 5 patients were given 25 IU and 5 patients were given 50 IU.
Even though the number of treated patients is low, there did not appear to be differences in
the adverse events profile between those who received 25 Iu and those who received 50 IU. The
investigators also previously injected 25 IU botulinum toxin towards the sphenopalatine
ganglion bilaterally (i.e. 25 IU in each side) in 10 patients suffering from intractable
chronic migraine. Doses of up to 25 IU have been injected in structures adjacent to the otic
ganglion, for instance in dystonia towards the lateral pterygoid muscle. Thus it was decided
for this study on injection towards the otic ganglion, to explore the safety of 12.5 and 25
IU of botulinum toxin.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Norwegian University of Science and Technology
Collaborator:
St. Olavs Hospital
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA