2023-504567-17-00招募中3 期
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
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 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).
研究概览
简要总结
To investigate if botulinum toxin A is more effective than placebo in the treatment of trigeminal neuralgia.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomization
- 盲法
- Double (Analyst, Investigator, Subject, Monitor, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
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).
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).
次要结局
- The proportion of subjects reaching ≥50% reduction in mean ADP during the evaluation period (week 2 to 5) compared with baseline (week -4 to -1).
- The proportion of subjects reaching ≥75% reduction in mean ADP during the evaluation period (week 2 to 5) compared with baseline (week -4 to -1).
- The difference in inflammatory biomarkers between the symptomatic side and the asymptomatic side.
- The proportion of subjects reaching ≥30% reduction in mean ADP during week 9 to 12 compared with baseline (week -4 to -1).
- The degree of change in inflammatory biomarkers in responders versus non-responders in BTX-A and placebo group.
- Change in mean number of daily pain paroxysms during the evaluation period (week 2 to 5) and week 9 to 12 compared with baseline (week -4 to -1) in BTX-A and placebo group.
- Proportion of subjects with a PGI-C scale response of “much improved” or “very much improved” at week 5 in BTX-A group and placebo group.
- Change from baseline to week 5 in the PENN-FPS-R score in BTX-A and placebo group.
- Proportion of subjects correctly guessing whether they received BTX-A or placebo.
- Proportion of dropouts caused by increased intake of trigeminal neuralgia medication or use of prohibited rescue medication in botulinum toxin A group compared to the placebo group.
- Proportion of subjects with side-effects registered in weeks 2 to 5 during treatment with botulinum toxin A compared with placebo
研究者
Henrik Schytz
Scientific
Rigshospitalet
研究点 (1)
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