Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Mi… (NCT04069897) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine
Norway170 participantsStarted 2019-10-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Informed and written consent.
✓. Male or female, between 18 and 70 years of age
✓. Masters a Scandinavian language at level sufficient to fully understand the written and verbal study information
✓. Migraine, with or without aura, fulfilling the International Classification of Headache Disorders (ICHD) III criteria 1.3. for chronic migraine at time of inclusion
✓. Chronic migraine at least for a period of 1 year prior to inclusion
✓. Debut of episodic migraine before the age of 50, and chronic migraine before the age of 65.
✓. The condition is pharmacologically refractory as defined in this study as insufficient treatment effect, contraindication(s) or intolerable side effect(s) of at least 3 medications from at least 2 of the following medication (drug) classes
✓. Beta-blockers
Exclusion criteria
✕. Allergy or hypersensitivity reactions to marcaine, lidocaine, xylocaine, adrenaline, any botulinum toxin or similar substances.
What they're measuring
1
Change from baseline in the mean monthly headache days at weeks 5 - 8 post intervention
Timeframe: week 5 through week 8 in the post-injection period