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

Henrik Schytz1 site in 1 country80 target enrollmentNovember 1, 2023

ConditionsTrigeminal Neuralgia

InterventionsIsotonic saline Botulinum toxin A

DrugsBotulinum toxin A

Overview

Phase: Phase 3
Intervention: Isotonic saline
Conditions: Trigeminal Neuralgia
Sponsor: Henrik Schytz
Enrollment: 80
Locations: 1
Primary Endpoint: Proportion of responders in botulunim toxin A and placebo group
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2023

End Date

October 1, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Henrik Schytz

Responsible Party

Sponsor Investigator

Principal Investigator

Henrik Schytz

Consultant, Associate Professor, DMSc, PhD

Danish Headache Center

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.
•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.

Arms & Interventions

Isotonic saline

Intervention: Isotonic saline

Botulinum toxin A

Intervention: Botulinum toxin A

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Biomarkers(Evaluation period (week 2 to 5) compared with baseline (week -4 to -1))
50 % reduction(Evaluation period (week 2 to 5) compared with baseline (week -4 to -1))
Dropouts(Up to 24 weeks)
75 % reduction(Evaluation period (week 2 to 5) compared with baseline (week -4 to -1))
Prolonged 30 % reduction(Week 9 to 12 compared with baseline (week -4 to -1))
Change in paroxysms(Evaluation period (week 2 to 5) and during weeks 9 to 12 compared with baseline (week -4 to -1))
Tear fluid CGRP(Evaluation period (week 2 to 5) compared with baseline (week -4 to -1))
PGI-C(Week 5)
PENN Facial Pain Scale-Revised (PENN-FPS-R)(Baseline to week 5)
Patient's guess(Evaluation period (week 2 to 5) compared with baseline (week -4 to -1))
Side effects(Up to 24 weeks)