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

Rigshospitalet0 个研究点目标入组 80 人开始时间: 2023年5月25日最近更新: 2024年7月22日

适应症

试验速览

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•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

•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).

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