Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine

This is a clinical trial to assess the efficacy of botox treatment of the sphenopalatine ganglion as an add-on treatment in drug resistant migraine. An injection targeting the ganglion is made possible by an image-guided device developed specifically for this purpose (MultiGuide) Study participants will be randomized to either placebo or botox after a 4 week run-in period. First, one injection will be given towards both the right and the left ganglion. After that there will be a follow-up of 12 weeks for efficacy and safety evaluation. The main efficacy measure is change in number of moderate to severe headache days before and after injection.

NCT Number	NCT04069897
Lead Sponsor	St. Olavs Hospital Collaborators: Norwegian University of Science and Technology, Oslo University Hospital, Haukeland University Hospital, Nordlandssykehuset HF
Conditions	Migraine Disorders
Enrollment	170 participants
Start Date	2019-10-01
Primary Completion	2025-06-13 (estimated)
Study Completion	2026-06-13 (estimated)
Updated on ClinicalTrials.gov	2026-08-11