Trigeminal NeuralgiaPhase 3NCT06315790
Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia
A Phase 3 study testing Botulinum toxin A and Isotonic saline in people with Trigeminal Neuralgia, run by Henrik Schytz at 1 site in Denmark.
Trial summary
This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers. The trial lasts 16 weeks, with a 4-week baseline phase and a 12-week randomization phase. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Botulinum toxin A and Isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2023to 1 Oct 2025
- Phase
- Phase 3
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of classical TN or idiopathic TN according to criteria of The International Classification of Headache Disorders 3rd edition.
- Age between 18 and 85 years.
- Subjects must experience pain defined as a minimum of three TN related pain paroxysms per day at least four days a week of an average intensity of 4 to 10, inclusive, on the 11-point NRS (0 = no pain; 10 = maximum pain imaginable) during the last 4 weeks to enter the baseline phase.
- During baseline phase subjects must experience pain defined as a minimum of three TN related pain paroxysms per day at least four days a week of an intensity of an average 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the last month to enter the treatment phase (to be randomized).
- Fluency in Danish.
Who cannot join
- Severe cardiovascular and cerebrovascular disease such as ischemic heart disease, myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions during the last three months.
- Expected poor compliance, i.e., considered unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge.
- Ongoing and unstable severe psychiatric disease.
- Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient.
- Change of TN treatment or treatment dose within two weeks prior to the baseline visit.
- Previous treatment with BTX-A for facial pain.
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- Loading treatment within 4 weeks with phenytoin or sodium valproate.
- Female subjects either pregnant, breastfeeding or with planned conception within the study period.
- Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study.
- Known allergy to any component of BTX-A.
- Infection at the proposed injection site.
- Known severe neuromuscular disorders or any degree of disorder affecting the neuromuscular transmission.
- Known comprised respiratory function.
- Member of investigational site staff or relative of the investigator.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center
Glostrup Municipality, 2600
Henrik Schytz, MD, +4528761824, henrik.winther.schytz.01@regionh.dkonh.dk
Henrik Schytz, MD
About this study
Official title: Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia: a Double-blind, Randomized, Placebo-controlled, Parallel-group Trial and Investigation of Neuro-inflammatory Biomarkers as Predictors of Efficacy
This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers. The trial lasts 16 weeks, with a 4-week baseline phase and a 12-week randomization phase. Four visits are planned: 1) Introduction and baseline data collection, 2) Medical evaluation and treatment assignment, 3) Follow-up with biomarker analysis, and 4) Trial conclusion interview. 80 participants will be included and randomized 1:1.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Botulinum toxin A, Isotonic saline
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin ADrug
Subcutaneously injections are given unilaterally in the face at predefined injection sites.
Isotonic salineOther
Subcutaneously injections are given unilaterally in the face at predefined injection sites.
| Study group | Role | What they receive |
|---|---|---|
| Isotonic saline | Placebo comparator | Not described Receives: Other: Isotonic saline |
| Botulinum toxin A | Active comparator | Not described Receives: Drug: Botulinum toxin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders in botulunim toxin A and placebo group
Responders are participants with a 30 % reduction in mean average daily pain score.
Measured: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Secondary outcomes (11)
Biomarkers
The degree of concentration change in inflammatory biomarkers (CGRP, CRP, TNF alpha, IL1, IL2, and IL6) in responders versus non-responders in BTX-A and placebo group.
Measured: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Tear fluid CGRP
The difference in tear fluid calcitonin gene-related peptide (CGRP) between the symptomatic side and the asymptomatic side.
Measured: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
50 % reduction
The proportion of subjects reaching ≥50% reduction in mean Average Daily Pain (ADP) intensity score
Measured: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
75 % reduction
The proportion of subjects reaching ≥75% reduction in mean ADP
Measured: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Prolonged 30 % reduction
The proportion of subjects reaching ≥30% reduction in mean ADP
Measured: Week 9 to 12 compared with baseline (week -4 to -1)
Change in paroxysms
Change in mean number of daily pain paroxysms n BTX-A group and placebo group
Measured: Evaluation period (week 2 to 5) and during weeks 9 to 12 compared with baseline (week -4 to -1)
PGI-C
Proportion of subjects with a Patient Global Impression of Change (PGI-C) scale response of "much improved" or "very much improved" in BTX-A and placebo group
Measured: Week 5
PENN Facial Pain Scale-Revised (PENN-FPS-R)
Change in the PENN-FPS-R
Measured: Baseline to week 5
Patient's guess
Proportion of subjects correctly guessing whether they received BTX-A or placebo
Measured: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Dropouts
Proportion of dropouts caused by increased intake of trigeminal neuralgia (TN) medication or use of rescue medication in BTX-A group compared to the placebo group through study completion.
Measured: Up to 24 weeks
Side effects
Proportion of subjects with side-effects registered in weeks 2 to 5 during treatment with BTX-A compared with placebo through study completion.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Nov 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henrik Schytz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Henrik Schytz, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315790
- Sponsor's protocol ID
- TN BTX-A Trial
- Status last verified
- Mar 2024
- First submitted
- 28 Aug 2023
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia: a Double-blind, Randomized, Placebo-controlled, Parallel-group Trial and Investigation of Neuro-inflammatory Biomarkers as Predictors of Efficacy
- ClinicalTrials.gov ID
- NCT06315790
- Acronym / sponsor ID
- TN BTX-A Trial
- Conditions
- Trigeminal Neuralgia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Henrik SchytzUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 18 Mar 2024 (actual)
- 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.
This is a double-blind randomized clinical trial comparing the pain reduction of individuals treated with BTX-A and placebo as well as evaluating possible changes in neuroinflammatory biomarkers. The trial lasts 16 weeks, with a 4-week baseline phase and a 12-week randomization phase. Four visits are planned: 1) Introduction and baseline data collection, 2) Medical evaluation and treatment assignment, 3) Follow-up with biomarker analysis, and 4) Trial conclusion interview. 80 participants will be included and randomized 1:1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotonic saline | Placebo comparator | Other: Isotonic saline |
| Botulinum toxin A | Active comparator | Drug: Botulinum toxin A |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of classical TN or idiopathic TN according to criteria of The International Classification of Headache Disorders 3rd edition.
- Age between 18 and 85 years.
- Subjects must experience pain defined as a minimum of three TN related pain paroxysms per day at least four days a week of an average intensity of 4 to 10, inclusive, on the 11-point NRS (0 = no pain; 10 = maximum pain imaginable) during the last 4 weeks to enter the baseline phase.
- During baseline phase subjects must experience pain defined as a minimum of three TN related pain paroxysms per day at least four days a week of an intensity of an average 4 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) during the last month to enter the treatment phase (to be randomized).
- Fluency in Danish.
Key exclusion criteria (14 listed)
- Severe cardiovascular and cerebrovascular disease such as ischemic heart disease, myocardial infarction or previous stroke or transient ischemic attack, major CVD interventions during the last three months.
- Expected poor compliance, i.e., considered unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge.
- Ongoing and unstable severe psychiatric disease.
- Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient.
- Change of TN treatment or treatment dose within two weeks prior to the baseline visit.
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 ASubcutaneously injections are given unilaterally in the face at predefined injection sites. | Drug | Botulinum toxin A |
| Isotonic salineSubcutaneously injections are given unilaterally in the face at predefined injection sites. | Other | Isotonic saline |
Primary outcome
Proportion of responders in botulunim toxin A and placebo group
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Responders are participants with a 30 % reduction in mean average daily pain score.
11 secondary outcomes
Biomarkers
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Tear fluid CGRP
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
50 % reduction
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
75 % reduction
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Prolonged 30 % reduction
Time frame: Week 9 to 12 compared with baseline (week -4 to -1)
Change in paroxysms
Time frame: Evaluation period (week 2 to 5) and during weeks 9 to 12 compared with baseline (week -4 to -1)
PGI-C
Time frame: Week 5
PENN Facial Pain Scale-Revised (PENN-FPS-R)
Time frame: Baseline to week 5
Patient's guess
Time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)
Dropouts
Time frame: Up to 24 weeks
Side effects
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Danish Headache Center
Glostrup Municipality, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin A and Isotonic saline in people with Trigeminal Neuralgia, run by Henrik Schytz at 1 site in Denmark.
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 5 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of responders in botulunim toxin A and placebo group (time frame: Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2024.