Using Botulinum Toxin A to Treat Trigeminal Neuralgia Pain

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 study is testing if Botulinum Toxin A can help reduce pain for people with trigeminal neuralgia.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Danish Headache Center (Academic / other)
• Locations: 1 site (Glostrup)
• Trial ID: NCT06315790 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Botulinum Toxin A (BTX-A) in reducing pain for patients suffering from trigeminal neuralgia. It is a double-blind, randomized study that includes a 4-week baseline phase followed by a 12-week treatment phase where participants receive either BTX-A or a placebo. The trial will assess pain reduction and changes in neuroinflammatory biomarkers over the course of the study. A total of 80 participants will be enrolled and randomized in a 1:1 ratio.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with a diagnosis of classical or idiopathic trigeminal neuralgia experiencing frequent and intense pain.

Not a fit: Patients with severe cardiovascular or cerebrovascular diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce pain for patients with trigeminal neuralgia, improving their quality of life.

How similar studies have performed: Previous studies have shown promising results with Botulinum Toxin A for various pain conditions, suggesting potential success in this approach for trigeminal neuralgia.

Eligibility criteria

Inclusion Criteria:

1. A diagnosis of classical TN or idiopathic TN according to criteria of The International Classification of Headache Disorders 3rd edition.
2. Age between 18 and 85 years.
3. 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.
4. 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).
5. Fluency in Danish.

Exclusion Criteria:

1. 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.
2. 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.
3. Ongoing and unstable severe psychiatric disease.
4. Anamnestic or clinical symptoms of any kind that are deemed relevant for study participation by the physician who examines the patient.
5. Change of TN treatment or treatment dose within two weeks prior to the baseline visit.
6. Previous treatment with BTX-A for facial pain.
7. Loading treatment within 4 weeks with phenytoin or sodium valproate.
8. Female subjects either pregnant, breastfeeding or with planned conception within the study period.
9. Female subject of childbearing potential who is unwilling to use an acceptable method of effective contraception during the study.
10. Known allergy to any component of BTX-A.
11. Infection at the proposed injection site.
12. Known severe neuromuscular disorders or any degree of disorder affecting the neuromuscular transmission.
13. Known comprised respiratory function.
14. Member of investigational site staff or relative of the investigator.

Where this trial is running

Glostrup

• Danish Headache Center — Glostrup, Denmark (Recruiting)

Conditions Trigeminal Neuralgia