Safety and efficacy of botulinum toxin A (Botox) in patients with trigeminal neuralgia

Phase 1

Recruiting

• Conditions: Trigeminal neuralgia; MedDRA version: 20.0Level: PTClassification code: 10044652Term: Trigeminal neuralgia Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-504567-17-00
• Lead Sponsor: Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-25
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

A diagnosis of classical trigeminal neuralgia or idiopathic trigeminal neuralgia according to criteria of The International Classification of Headache Disorders 3rd edition., Age between 18 and 85 years, Subjects must experience pain defined as minimum one TN related pain paroxysm per day of an average intensity of 3 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 minimum one TN related pain paroxysm per day of an average intensity of 3 to 10, inclusive, on the 11-point NRS (0= no pain; 10= maximum pain imaginable) 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 trigeminal neuralgia treatment or treatment dose within two weeks prior to the baseline visit., Previous treatment with botulinum toxin 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 (see protocol for acceptable methods).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate if botulinum toxin A is more effective than placebo in the treatment of trigeminal neuralgia.;Secondary Objective: To investigate if neuroinflammatory biomarkers are predictive of botulinum toxin A treatment response in trigeminal neuralgia;Primary end point(s): The proportion of responders in botulinum toxin A (BTX-A) and placebo group during the evaluation period (week 2 to 5) compared with baseline (week -4 to -1) (see protocol for definition of responders).