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

NCT06315790 | Recruiting Phase 3 DMC

• 1 other identifier: TN BTX-A Trial
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of responders in botulunim toxin A and placebo group

  Responders are participants with a 30 % reduction in mean average daily pain score.

  Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)

Secondary Outcomes (11)

• Biomarkers

  Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)

• Tear fluid CGRP

  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)

• 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)

Other Outcomes (5)

• Pure paroxysmal pain vs. paroxysms with concomitant pain

  Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)

• Idiopathic vs. classical trigeminal neuralgia

  Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)

• Patients with severe pain

  Evaluation period (week 2 to 5) compared with baseline (week -4 to -1)

Study Arms (2)

Isotonic saline

PLACEBO COMPARATOR

Other: Isotonic saline

Botulinum toxin A

ACTIVE COMPARATOR

Drug: Botulinum toxin A

Interventions

Botulinum toxin A DRUG

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

Botulinum toxin A

Isotonic saline OTHER

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

Isotonic saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Henrik Schytz: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant, Associate Professor, DMSc, PhD

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: March 18, 2024
• Study Start: November 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)