NCT07361549招募中2 期
Localized Injection of Lidocaine Via the Middle Meningeal Artery for 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9月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Headache Impact Test-6 Scores (1 Month)
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
- Double (Participant, Investigator)
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
- •Diagnosis of chronic migraine
- •Referred for diagnostic cerebral angiography to screen for intracranial pathology
- •Written informed consent able to be obtained from subject
排除标准
- •Baseline HIT-6 score less than 50
- •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
Sham
Sham Comparator
Intra-arterial saline
干预措施: Saline (Drug)
Treatment
Experimental
Intra-arterial lidocaine
干预措施: Lidocaine (drug) (Drug)
结局指标
主要结局
Change in Headache Impact Test-6 Scores (1 Month)
时间窗: From baseline to 1 month follow-up
Difference in Headache Impact Test-6 Scores, with larger decreases in scores correlating with improvement in symptoms
次要结局
- Change in Numeric Pain Scores(From baseline to periprocedural)
- Change in Migraine Disability Assessment Scores(From baseline to 3 month follow-up)
- Change in Headache Impact Test-6 Scores Over Time (2 Months)(From baseline to 2 month follow-up)
- Change in Headache Impact Test-6 Scores Over Time (3 Months)(From baseline to 3 month follow-up)
- Proportion with Substantial or Severe Headache Impact Test-6 Scores (1 Month)(From baseline to 1 month follow-up)
- Proportion with Substantial or Severe Headache Impact Test-6 Scores (2 Months)(From baseline to 2 month follow-up)
- Proportion with Substantial or Severe Headache Impact Test-6 Scores (3 Months)(From baseline to 3 month follow-up)
- Proportion with Low Patient Global Impression of Change Scores (Post-Treatment)(From baseline to periprocedural)
- Proportion with Low Patient Global Impression of Change Scores (1 Month)(From baseline to 1 month follow-up)
- Proportion with Low Patient Global Impression of Change Scores (2 Months)(From baseline to 2 month follow-up)
- Proportion with Low Patient Global Impression of Change Scores (3 Months)(From baseline to 3 month follow-up)
- Related or Serious Adverse Events(From post-treatment to 1 week)
- New Stroke or All-Cause Death(From post-treatment to 1 month follow-up)
研究者
Daniel A Tonetti, MD
Assistant Professor of Neurological Surgery
The Cooper Health System
研究点 (1)
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