Safety and Efficacy of Botulinum Toxin A in Patients With Trigeminal Neuralgia

NCT ID: NCT06315790

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2025-10-01

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Isotonic saline

Group Type: PLACEBO_COMPARATOR

Isotonic saline

Intervention Type: OTHER

Subcutaneously injections are given unilaterally in the face at predefined injection sites.

Botulinum toxin A

Group Type: ACTIVE_COMPARATOR

Botulinum toxin A

Intervention Type: DRUG

Subcutaneously injections are given unilaterally in the face at predefined injection sites.

Interventions

Botulinum toxin A

Subcutaneously injections are given unilaterally in the face at predefined injection sites.

Intervention Type: DRUG

Isotonic saline

Subcutaneously injections are given unilaterally in the face at predefined injection sites.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henrik Schytz

OTHER

Sponsor Role: lead

Responsible Party

Henrik Schytz

Consultant, Associate Professor, DMSc, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Danish Headache Center

Glostrup Municipality, , Denmark

Site Status: RECRUITING

Countries

Denmark

Facility Contacts

Henrik Schytz, MD

Role: primary

henrik.winther.schytz.01@regionh.dkonh.dk

+4528761824

Other Identifiers

TN BTX-A Trial

Identifier Type: -

Identifier Source: org_study_id