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Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Migraine | Clinical Trials | Clareo Health

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

NCT04069897•St. Olavs Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Informed and written consent.
•2. Male or female, between 18 and 70 years of age
•3. Masters a Scandinavian language at level sufficient to fully understand the written and verbal study information
•4. Migraine, with or without aura, fulfilling the International Classification of Headache Disorders (ICHD) III criteria 1.3. for chronic migraine at time of inclusion
•5. Chronic migraine at least for a period of 1 year prior to inclusion
•6. Debut of episodic migraine before the age of 50, and chronic migraine before the age of 65.
•7. 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
•1. Beta-blockers
•2. RA(A)S-inhibitors
•3. Calcium-antagonists
+8 more criteria

Exclusion Criteria

•1. Allergy or hypersensitivity reactions to marcaine, lidocaine, xylocaine, adrenaline, any botulinum toxin or similar substances.
•2. Subject is unable to differentiate migraine from other concomitant headaches.
•3. Subject with secondary headache conditions, with the exception of medication overuse headache.
•4. Non-responder in regular clinical practice to preventive medications from ≥6 of the following 7 drug classes:
•1. Beta-blockers
•2. RA(A)S-inhibitors
•3. Calcium-antagonists
•4. Antiepileptic drugs
•5. Tricyclic antidepressants
•6. Botulinum toxin A
+31 more criteria

Locations (4)

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

Key Dates

Start Date

October 1, 2019

Primary Completion Date

June 13, 2025

Completion Date

June 1, 2026

Last Updated

August 5, 2025

Enrollment

170

ACTUAL participants

Conditions

Migraine Disorders

Interventions

Botulinum toxin type A

DRUG

placebo

DRUG

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RECRUITING

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RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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