Trigeminal NeuralgiaPhase 1/2NCT02662972
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
A Phase 1/2 study testing Botulinum Toxin Type A in people with Trigeminal Neuralgia and Headache Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trigeminal Neuralgia, Headache Disorders
- What is being tested?
- Botulinum Toxin Type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- May 2016to 1 Nov 2018
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed and written consent
- Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria
- Unsatisfactory effect of pharmacological treatment
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Neuroscience, Norwegian University of Science and Technology
Trondheim
About this study
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
- Being tested
- Botulinum Toxin Type A
- Keywords
- Nerve block, Sphenopalatine Ganglion Block, Botulinum Toxins, Type A
- Medical subject headings
- Trigeminal Neuralgia, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Botox, BTA
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for the follow-up period of 12 weeks
Secondary outcomes (4)
Number of attacks with trigeminal neuralgia
Measured: 12 weeks
Intensity of the attacks
expressed as score on Visual analogue scale (VAS) for pain
Measured: 12 weeks
Number of attacks with trigeminal neuralgia per 4 weeks per patient
Measured: 12 weeks
Number of doses of analgesics per 4 weeks per patient
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startMay 2016
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Erling A Tronvik, PhD, MD, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662972
- Sponsor's protocol ID
- BTATN2015
- Other IDs
- 2015-002643-33, 2015
- Status last verified
- Jul 2019
- First submitted
- 26 Nov 2015
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31342515
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues.
- ClinicalTrials.gov ID
- NCT02662972
- Acronym / sponsor ID
- BTATN2015
- Conditions
- Trigeminal Neuralgia, Headache Disorders
- Keywords
- Nerve block, Sphenopalatine Ganglion Block, Botulinum Toxins, Type A
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- May 2016 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin | Experimental | Drug: Botulinum Toxin Type AThe patients will be injected with 25 IU of Botulinum Toxin Type A towards the sphenopalatine ganglion in the affected side (ipsilateral to the pain) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed and written consent
- Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria
- Unsatisfactory effect of pharmacological treatment
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type AAlso: Botox, BTA | Drug | Botulinum Toxin |
Primary outcome
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.
4 secondary outcomes
Number of attacks with trigeminal neuralgia
Time frame: 12 weeks
Intensity of the attacks
Time frame: 12 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2019.
- Results publication: PubMed 31342515Crespi 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.
Related trials for Trigeminal Neuralgia
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
RecruitingEarly Phase 1
Trigeminal Evoked Responses to Improve Rhizotomy
Trigeminal Neuralgia, Rhizotomy
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingPhase 1/2
RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia
Trigeminal Neuralgia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erling A Tronvik, PhD, MD principal investigator
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Botulinum Toxin Type A in people with Trigeminal Neuralgia and Headache Disorders, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: for the follow-up period of 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02662972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.