Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.

Trigeminal Neuralgia Clinical Trial

Official title:

Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662972
• Other study ID #: BTATN2015
• Secondary ID: 2015-002643-33
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2016
• Est. completion date: November 1, 2018

Study information

• Verified date: July 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ganglion Cysts
• Headache
• Headache Disorders
• Neuralgia
• Trigeminal Neuralgia

Intervention

Drug:
• Botulinum Toxin Type A

Locations

Country	Name	City	State
Norway	Department of Neuroscience, Norwegian University of Science and Technology	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Crespi J, Bratbak D, Dodick DW, Matharu M, Jamtøy KA, Tronvik E. Pilot Study of Injection of OnabotulinumtoxinA Toward the Sphenopalatine Ganglion for the Treatment of Classical Trigeminal Neuralgia. Headache. 2019 Jul 25. doi: 10.1111/head.13608. [Epub a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	Number of adverse events. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations.	for the follow-up period of 12 weeks
Secondary	Number of attacks with trigeminal neuralgia		12 weeks
Secondary	Intensity of the attacks	expressed as score on Visual analogue scale (VAS) for pain	12 weeks
Secondary	Number of attacks with trigeminal neuralgia per 4 weeks per patient		12 weeks
Secondary	Number of doses of analgesics per 4 weeks per patient		12 weeks