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

NCT02662972 | Completed Phase 1 DMC

• 2 other identifiers: BTATN20152015-002643-33
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Trigeminal Neuralgia; Headache Disorders

Keywords

Nerve block; Sphenopalatine Ganglion Block; Botulinum Toxins, Type A

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of attacks with trigeminal neuralgia

  12 weeks

• Intensity of the attacks

  12 weeks

• 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

Study Arms (1)

Botulinum Toxin

EXPERIMENTAL

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

Interventions

Botulinum Toxin Type A DRUG

Also known as: Botox, BTA

Botulinum Toxin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, Norway

Location

Related Publications (1)

• 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.

  PMID: 31342515 RESULT

MeSH Terms

Conditions

Trigeminal Neuralgia; Headache Disorders

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Erling A Tronvik, PhD, MD

  Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2015
• First Posted: January 26, 2016
• Study Start: May 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: July 29, 2019

Record last verified: 2019-07

Locations

NO (1)