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

This study is currently recruiting participants.
Verified November 2017 by Norwegian University of Science and Technology
Sponsor:
ClinicalTrials.gov Identifier:
NCT02662972
First Posted: January 26, 2016
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose
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 Intervention Phase
Trigeminal Neuralgia Headache Disorders Drug: Botulinum Toxin Type A Phase 1 Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Number of attacks with trigeminal neuralgia [ Time Frame: 12 weeks ]
  • Intensity of the attacks [ Time Frame: 12 weeks ]
    expressed as score on Visual analogue scale (VAS) for pain

  • Number of attacks with trigeminal neuralgia per 4 weeks per patient [ Time Frame: 12 weeks ]
  • Number of doses of analgesics per 4 weeks per patient [ Time Frame: 12 weeks ]

Estimated Enrollment: 10
Actual Study Start Date: May 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662972


Contacts
Contact: Joan Crespi, MD joan.crespi@ntnu.no
Contact: Daniel F Bratbak, MD daniel.f.bratbak@ntnu.no

Locations
Norway
Department of Neuroscience, Norwegian University of Science and Technology Recruiting
Trondheim, Norway
Contact: Erling A Tronvik, PhD, MD       erling.tronvik@ntnu.no   
Contact: Daniel F Bratbak, MD       daniel.f.bratbak@ntnu.no   
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
  More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT02662972     History of Changes
Other Study ID Numbers: BTATN2015
2015-002643-33 ( EudraCT Number )
First Submitted: November 26, 2015
First Posted: January 26, 2016
Last Update Posted: November 8, 2017
Last Verified: November 2017

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:
Headache
Neuralgia
Ganglion Cysts
Trigeminal Neuralgia
Headache Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Trigeminal Nerve Diseases
Facial Neuralgia
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases
Brain Diseases
Central Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action