Back to resultsBotulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
Primary Purpose
Trigeminal Neuralgia, Headache Disorders
Status
Completed
Phase
Phase 1
Locations
Norway
Study Type
Interventional
Intervention
Botulinum Toxin Type A
Sponsored by
About this trial
This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring Nerve block, Sphenopalatine Ganglion Block, Botulinum Toxins, Type A
Eligibility 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
Sites / Locations
- Department of Neuroscience, Norwegian University of Science and Technology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Botulinum Toxin
Arm Description
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)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of attacks with trigeminal neuralgia
Intensity of the attacks
expressed as score on Visual analogue scale (VAS) for pain
Number of attacks with trigeminal neuralgia per 4 weeks per patient
Number of doses of analgesics per 4 weeks per patient
Full Information
NCT ID
NCT02662972
First Posted
November 26, 2015
Last Updated
July 26, 2019
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02662972
Brief Title
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
Official Title
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia, Headache Disorders
Keywords
Nerve block, Sphenopalatine Ganglion Block, Botulinum Toxins, Type A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Botulinum Toxin
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Botulinum Toxin Type A
Other Intervention Name(s)
Botox, BTA
Primary Outcome Measure Information:
Title
Number of adverse events
Description
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.
Time Frame
for the follow-up period of 12 weeks
Secondary Outcome Measure Information:
Title
Number of attacks with trigeminal neuralgia
Time Frame
12 weeks
Title
Intensity of the attacks
Description
expressed as score on Visual analogue scale (VAS) for pain
Time Frame
12 weeks
Title
Number of attacks with trigeminal neuralgia per 4 weeks per patient
Time Frame
12 weeks
Title
Number of doses of analgesics per 4 weeks per patient
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erling A Tronvik, PhD, MD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neuroscience, Norwegian University of Science and Technology
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
31342515
Citation
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.
Results Reference
result
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Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
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