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

• Sponsor: Norwegian University of Science and Technology (Other)
• Overall Status: Completed
• CT.gov ID: NCT02662972
• Collaborator: St. Olavs Hospital (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 30
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trigeminal Neuralgia; Headache Disorders	Drug: Botulinum Toxin Type A	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
• Actual Study Start Date: May 1, 2016
• Actual Primary Completion Date: Nov 1, 2018
• Actual Study Completion Date: Nov 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Botulinum Toxin 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)	Drug: Botulinum Toxin Type A; Other Names: Botox BTA

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of attacks with trigeminal neuralgia [12 weeks]

2. Intensity of the attacks [12 weeks]

   expressed as score on Visual analogue scale (VAS) for pain

3. Number of attacks with trigeminal neuralgia per 4 weeks per patient [12 weeks]

4. Number of doses of analgesics per 4 weeks per patient [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neuroscience, Norwegian University of Science and Technology	Trondheim		Norway

Sponsors and Collaborators

• Norwegian University of Science and Technology
• St. Olavs Hospital

Investigators

• Principal Investigator: Erling A Tronvik, PhD, MD, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Norwegian University of Science and Technology
• ClinicalTrials.gov Identifier: NCT02662972
• Other Study ID Numbers: BTATN2015; 2015-002643-33
• First Posted: Jan 26, 2016
• Last Update Posted: Jul 29, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Norwegian University of Science and Technology: Nerve block; Sphenopalatine Ganglion Block; Botulinum Toxins, Type A
• Additional relevant MeSH terms: Ganglion Cysts; Trigeminal Neuralgia; Neuralgia; Headache Disorders; Headache; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

No Results Posted as of Jul 29, 2019