Spots Global Cancer Trial Database for Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine
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Trial Identification
Brief Title: Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine
Official Title: Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine
Study ID: NCT04069897
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Haukeland University Hospital, department of Neurology, Bergen, , Norway
Nordland Hospital, department of Neurology, Bodø, , Norway
Nevroklinikken Universitetet i Oslo, Oslo Universitetssykehus HF, Oslo, , Norway
St Olavs Hospital, Trondheim University Hospital, Trondheim, , Norway
Contact Details
Name: Geir Bråthen, md phd
Affiliation: St. Olavs Hospital
Role: STUDY_DIRECTOR
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