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

NCT06315790 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-03-18

No results posted yet for this study

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

Interventions

DRUG

Botulinum toxin A

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

OTHER

Isotonic saline

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

Sponsors & Collaborators

  • Henrik Schytz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-10-01
Completion
2025-10-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06315790 on ClinicalTrials.gov