Clinical trial NCT02019017: Botox Injection in Treatment of Cluster Headache
Official title: Endoscopic Block of the Sphenopalatine Ganglion With Botulinum Toxin in Intractable Cluster Headache - Safety Issues
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cluster Headache
Keywords: Cluster Headache
Botulinum Toxin Type A
Sphenopalatine Ganglion Block
Autonomic Nerve Block
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2013-12-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cluster headache is an intense and powerful, one-sided headache accompanied by involuntary symptoms such as red eye, droopy eyelids, flow of tears, small pupils and one-sided facial sweating. The headache is believed to be the most intense of all headaches and among many is totally disabling and of great personal and social consequences. For a small group of patients with episodic and most chronic form, drug therapy has little effect. For them, surgery can be a solution.

Neuroradiology has found evidence of a possible original activation of cluster headache from the portion of the brain called hypothalamus. Furthermore, an activation of the parasympathetic nervous system through the sphenopalatine ganglion, which may also explain some of the one-sided involuntary symptoms, is suspected in cluster headache. Injection of Botulinum toxin type A (BTA) inhibits secretion of synaptic acetylcholine resulting in nerve signals being blocked. The duration of such a blockade is believed to be 3-9 months.

The purpose of the present study is to develop and evaluate a new surgical procedure with injection of BTA for blocking of the sphenopalatine ganglion. The goal is to relieve the symptoms of refractory cluster headache with a minimal invasive procedure.

The main objective of the project is to determine the safety of BTA injection in the area of the sphenopalatine ganglion of refractory cluster headache and detect the adverse events. Secondary objectives are to identify the changes of headache attacks by the method used.


Eligibility criteria: Inclusion Criteria:

* Informed and written consent
* Cluster headaches defined in ICHD-2 criteria, duration of periods of attacks normally more than 2 months and insufficient effect of available prophylactic treatment

Exclusion Criteria:

* Heart or lung disease
* Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure, related to injection or anesthesia
* Psychiatric illness that hinders participation in the study
* Known pregnancy or breast feeding
* Inadequate use of contraceptives
* Overuse or abuse of opioids
* Abuse of medications, narcotics or alcohol
* Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication
* Treatment with medication that can interact with botulinum toxin type A

Primary outcomes:
measure: Safety aspects / Number of adverse events and number of participants with adverse events as a measure of safety
timeFrame: For the follow-up period of 6 months
Secondary outcomes:
measure: Cluster headache attack frequency
timeFrame: Average number of attacks of baseline compared to average of week 3 and 4 after injection
measure: Hours with cluster headache
timeFrame: Average of baseline compared to average of week 3 and 4 after injection
measure: Days with cluster headache
timeFrame: Average of baseline compared to average of week 3 and 4 after injection
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Neuroscience, Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Daniel F Bratbak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bratbak DF, Nordgard S, Stovner LJ, Linde M, Folvik M, Bugten V, Tronvik E. Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache. Cephalalgia. 2016 May;36(6):503-9. doi: 10.1177/0333102415597891. Epub 2015 Jul 31.