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

July 26, 2019 updated by: Norwegian University of Science and Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Department of Neuroscience, Norwegian University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
for the follow-up period of 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

November 26, 2015

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

July 29, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTATN2015
  • 2015-002643-33 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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