NCT07361549尚未招募2 期
Localized Injection of Lidocaine Via the Middle Meningeal Artery for Intractable Headache Treatment: A Randomized, Double-Blinded, Parallel Phase 2 Clinical Trial
Daniel A Tonetti, MD1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年3月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Headache Impact Test-6 Scores
研究概览
简要总结
The goal of this clinical trial is to test whether injecting lidocaine into two blood vessels of the brain can help treat chronic headaches (migraines)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or above
- •Referred for diagnostic angiography
- •Diagnosis of intractable migraine
- •Written informed consent able to be obtained from subject
排除标准
- •Baseline HIT-6 score less than 60 (severe)
- •Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- •Concomitant intracranial pathology (eg, intracranial malignancy)
- •Known hypersensitivity and/or contraindication to lidocaine or local anesthetics of the amide type
- •Taking chronic medications that, when co-administered with lidocaine and other local anesthetics, are at increased risk of developing methemoglobinemia (nitrates/nitrites, local anesthetics, antineoplastic agents, antibiotics, antimalarials, anticonvulsants, acetaminophen, metoclopramide, quinine, sulfasalazine)
- •Known contraindications for angiography (eg, ESRD not requiring hemodialysis). Patients with contrast allergy with be premeditated with diphenhydramine and steroids.
- •Contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC)
- •Concurrent participation in another research protocol for investigation of an experimental therapy
- •Per DSA imaging, presence of a cerebrovascular pathology known to cause headache (eg, arteriovenous malformation, dural arteriovenous fistula)
- •Per DSA imaging, presence of anastomosis or anatomical variation (eg, branches of middle meningeal artery) that could lead to increased procedural risk
- •Per DSA imaging, lack of endovascular access to either middle meningeal artery, or origin of the middle meningeal artery other than from the external carotid artery
- •Known or suspected inability to adhere to study protocol or protocol requirements, as per discretion of the Investigator or treating provider
研究组 & 干预措施
Treatment
Experimental
Intra-arterial lidocaine
干预措施: Lidocaine (drug) (Drug)
Sham
Sham Comparator
Intra-arterial saline
干预措施: Saline (Drug)
结局指标
主要结局
Change in Headache Impact Test-6 Scores
时间窗: From baseline to 4 week follow-up
Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms
次要结局
未报告次要终点
研究者
Daniel A Tonetti, MD
Assistant Professor of Neurological Surgery
The Cooper Health System
研究点 (1)
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