Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
St. Olavs Hospital
Collaborators:
Haukeland University Hospital Nordlandssykehuset HF Norwegian University of Science and Technology Oslo University Hospital
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A