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

Phase 1

Completed

• Conditions: Trigeminal Neuralgia; Headache Disorders
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT02662972
• Lead Sponsor: Norwegian University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-26
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-26
• Study Start: 2016-05
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botulinum Toxin	Botulinum Toxin Type A	The patients will be injected with 25 IU of Botulinum Toxin Type A towards the sphenopalatine ganglion in the affected side (ipsilateral to the pain)

Primary Outcome Measures

Name	Time	Method
Number of adverse events	for the follow-up period of 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Number of attacks with trigeminal neuralgia	12 weeks
Intensity of the attacks	12 weeks	expressed as score on Visual analogue scale (VAS) for pain
Number of attacks with trigeminal neuralgia per 4 weeks per patient	12 weeks
Number of doses of analgesics per 4 weeks per patient	12 weeks

Trial Locations

Locations (1)

Department of Neuroscience, Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway