Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache (BASIC)

  • STATUS
    Recruiting
  • End date
    Sep 21, 2025
  • participants needed
    112
  • sponsor
    Norwegian University of Science and Technology
Updated on 21 March 2022
botulinum toxin
migraine
lithium
botulinum toxin type a
ganglion
verapamil
headache disorders

Summary

Cluster headache is a primary headache condition characterized by clusters of one-sided, high-intensity pain attacks. The headache may be episodic or chronic. Treatment options are limited and their effects unsatisfactory. An important nerve pathway involved in the pain attacks has a switching station at the sphenopalatine ganglion (SPG) located in the depth of the facial bones. SPG is a known therapy target for cluster headache. The area can be identified on CT images, but is difficult to access due to its location. Thus, the Multiguide navigation system has been developed to enable precise delivery of the drugs that target SPG activity. In Trondheim, two phase 1 / Phase 2 study have been carried out using botulinum toxin A (Botox®) against SPG in patient with chronic cluster headache and chronic migraine. The results indicate that such a treatment strategy is safe and beneficial. The current study is a randomized, placebo-controlled, triple-blinded study to investigate whether precise single-injection of botulinum toxin A reduces the frequency of attacks in chronic cluster headache .

Details
Condition Cluster Headache
Treatment Placebo, Botulinum Toxin Type A
Clinical Study IdentifierNCT03944876
SponsorNorwegian University of Science and Technology
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Informed and written consent
Male or female, 18-85 years of age
Headache attacks fulfilling the International Classification of Headache Disorders (ICHD) III criteria for chronic cluster headache (CCH) 3.1.2
Dominant headache laterality with ≥ 80% of cluster headache attacks on one side
Subject reports ≥ 8 cluster attacks/week on the side of their dominant headache laterality in the 3 months prior to inclusion and in the baseline period
The condition is pharmacologically refractory defined as suboptimal effect or intolerable side effects or contraindication for verapamil or lithium or suboccipital steroid injection
Subject agrees to maintain current preventive headache medication regimens (no change in type, frequency, or dose) during the whole study period
Subject is able to differentiate concomitant headaches from cluster headache
In case of women of childbearing potential (WOCBP) they have to be using highly effective contraception in a period of 4 weeks after injection
Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria

Subject has had a change in type, dosage or dose frequency of preventive headache medications < 1 months prior to baseline/screening or 5 half-lives, whichever is longer.1
Subject has had a change in type, dosage or dose frequency of preventive headache medications during the baseline period, eg. prior to IMP administration
Non-responder to both oxygen and triptan
Non-responder in regular clinical practice at the discretion of the investigator to ≥4 of the listed preventive medications
Verapamil
Lithium
Topiramate
Valproate
Greater occipital nerve (GON) block
CGRP-antagonist
Participation in a clinical study of a new chemical entity or a prescription medicine
within 2 months before study drug administration or 5 half-lives, whichever is
Subject is currently participating or has participated in the last 3 months in another clinical study in which the subject has, is, or will be exposed to an investigational or non-investigational drug or device
longer
Allergy or hypersensitivity reactions to marcaine, lidocaine, xylocaine, adrenaline, any botulinum toxin or similar substances
Abuse of drugs or alcohol
Treatment with pharmacological substances that may interact with BTA (aminoglycosides, spectinomycin, neuromuscular blockers, both depolarizing agents (such as succinylcholine) or non-depolarizing (tubocurarine derivates), lincosamides, polymyxins, quinidine, magnesium sulfate or anticholinesterases.)
WOCBP that do not adhere to the requirements for HEC, as noted in inclusion criteria 9 and outlined in section 3.3
Use of opioids for ≥10 days per month
Pregnancy or breastfeeding in the study period
Subject has undergone facial surgery in the area of the pterygopalatine fossa or zygomaticomaxillary buttress ipsilateral to the planned injection site that, in the opinion of the Investigator, may lead to an inability to properly conduct the procedure
Facial anomaly or trauma which renders the procedure difficult.2
Subject currently has an active oral or dental abscess or a local infection at the site of injection based on present symptoms
Subject has been diagnosed with any major infectious processes such as osteomyelitis, or primary or secondary malignancies involving the face that have been active or required treatment in the past 6 months
Patients exhibiting a high degree of comorbidity and/or frailty associated with reduced life expectancy or high likelihood of hospitalization, at the discretion of the investigator
Patients with comorbid psychiatric disorders with psychotic or other symptoms making compliance with the study protocol difficult, at the discretion of the investigator
Patient with active infectious disease or infections that warrants special infection control measures, such as human immunodeficiency virus, tuberculosis, or chronic hepatitis B or C infection
Subject has had previous radiofrequency ablation, balloon compression, gamma knife, or chemical denervation (e.g. glycerol treatments) of the ipsilateral trigeminal ganglion or any branch of the trigeminal nerve
Patient with disorders that are known contraindication for Botox® treatment, especially neuromuscular disorders such as motorneuron disorders and myasthenic syndromes
Subject has had previous radiofrequency ablation (including non-lesional pulsed radiofrequency), balloon compression, gamma knife, or chemical denervation (e.g. glycerol treatments) of the ipsilateral SPG
Subject is currently or has been previously treated with occipital nerve stimulation or deep brain stimulation
Subject has had blocks of short-acting anaesthetics of the ipsilateral SPG in the last 3 months
Subject has undergone onabotulinumtoxinA injections of the head and/or neck or has had an occipital nerve block in the last 3 months
Subject is anticipated to require any excluded medication, device, or procedure during the study
Subject has a history of bleeding disorders and in the opinion of the Investigator, may lead to an inability to properly conduct the procedure
Subject has a history of coagulopathy
Subject is unable to stop antithrombotic medication, eg. anticoagulants and/or antiplatelet therapy, before procedure
The subject has been diagnosed with another trigeminal autonomic cephalalgia or trigeminal neuralgia
The patient cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator, for any of the following reasons
mentally or legally incapacitated or unable to give consent for any reason
in custody due to an administrative or a legal decision, under tutelage, or being admitted to a sanatorium or social institution
The patient is a study centre employee who is directly involved in the study or the
relative of such an employee
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