Skip to main content
OpenTrials
Completed

NCT Number: NCT02662972

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Other names: Botox, BTA

Primary outcomes

  1. Number of adverse events

    Time frame: 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 outcomes

  1. Number of attacks with trigeminal neuralgia

    Time frame: 12 weeks

  2. Intensity of the attacks

    Time frame: 12 weeks

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

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

    Time frame: 12 weeks

  4. Number of doses of analgesics per 4 weeks per patient

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 26, 2016
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.