Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache
Status:
Recruiting
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
Summary
Cluster headache is a primary headache condition characterized by clusters of one-sided,
high-intensity pain attacks. The headache may be episodic or chronic. Treatment options are
limited and their effects unsatisfactory. An important nerve pathway involved in the pain
attacks has a switching station at the sphenopalatine ganglion (SPG) located in the depth of
the facial bones. SPG is a known therapy target for cluster headache. The area can be
identified on CT images, but is difficult to access due to its location. Thus, the Multiguide
navigation system has been developed to enable precise delivery of the drugs that target SPG
activity. In Trondheim, two phase 1 / Phase 2 study have been carried out using botulinum
toxin A (Botox®) against SPG in patient with chronic cluster headache and chronic migraine.
The results indicate that such a treatment strategy is safe and beneficial. The current study
is a randomized, placebo-controlled, triple-blinded study to investigate whether precise
single-injection of botulinum toxin A reduces the frequency of attacks in chronic cluster
headache .
Phase:
Phase 3
Details
Lead Sponsor:
Norwegian University of Science and Technology
Collaborators:
Catholic University of Valencia Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta St. Olavs Hospital University College, London University Hospital, Essen
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A