Clinical trial NCT02662972: Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
Official title: Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Trigeminal Neuralgia
Headache Disorders
Keywords: Nerve block
Sphenopalatine Ganglion Block
Botulinum Toxins, Type A
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2016-01-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered surgery. There are different types of procedures and most of them are complex with a risk for complications. The researchers want to start a pilot study on 10 patients with a new surgical technique using neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an important role in facial pain. There have been a few trials trying to block this structure in trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers technique requires local anesthesia only (awake patient). The researchers believe that this treatment can become a "low threshold"-treatment for patients who do not have enough effect with pharmacological treatment and a better alternative to other complex surgical approaches. Using this new neuronavigation system the researchers can reach this neural structure with high precision.


Eligibility criteria: Inclusion Criteria:

* Informed and written consent
* Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria
* Unsatisfactory effect of pharmacological treatment

Exclusion Criteria:

* Microvascular decompression is seen as a better alternative
* 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
* 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
* Anomalies which hinder or impede the used method of injection
* 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: Number of adverse events
timeFrame: for the follow-up period of 12 weeks
Secondary outcomes:
measure: Number of attacks with trigeminal neuralgia
timeFrame: 12 weeks
measure: Intensity of the attacks
timeFrame: 12 weeks
measure: Number of attacks with trigeminal neuralgia per 4 weeks per patient
timeFrame: 12 weeks
measure: Number of doses of analgesics per 4 weeks per patient
timeFrame: 12 weeks
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: Erling A Tronvik, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Crespi J, Bratbak D, Dodick DW, Matharu M, Jamtoy KA, Tronvik E. Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia. Headache. 2019 Sep;59(8):1229-1239. doi: 10.1111/head.13608. Epub 2019 Jul 25.