NCT06462781已完成1 期
Intra-Arterial Injection of Lidocaine and Glucocorticoid in the Treatment of Intractable Headaches: A Non-Randomized, Open-Label Phase 1 Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number of Adverse Events
研究概览
简要总结
The goal of this clinical trial is to test whether injecting lidocaine and steroids into two blood vessels of the brain can help treat chronic headaches (migraines).
The main questions this study aims to answer: is this treatment safe for chronic migraine patients?
Participants will:
- Be treated once with lidocaine and steroid infused into the middle meningeal arteries (two blood vessels in the brain).
- Attend appointments scheduled 1 week, 6 weeks, and 12 weeks after the treatment for a checkup.
- Keep a log of their symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female greater than or equal to 18 years of age.
- •Documentation of a diagnosis of intractable migraine without aura, including failure of at least four classes of preventative drugs. Either intolerance or side effects requiring discontinuation or adequate trial at therapeutic dose without relief constitutes failure of therapy.
- •Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
排除标准
- •Pregnant, breastfeeding, or unwilling to practice contraception during participation in the study. Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants, or injections), (3) barrier methods (such as condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
- •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.
- •Patients with concomitant intracranial pathology (e.g., intracranial malignancy).
- •Blood glucose level on screening complete metabolic blood panel > 400 mg/dL.
- •Patients with known hypersensitivity and/or contraindication to either lidocaine hydrochloride or methylprednisolone sodium succinate, including:
- •Patients with known history of hypersensitivity to local anesthetics of the amide type.
- •Patients with systemic fungal infections.
- •Patients with known or suspected hypersensitivity to cow's milk or its components or other dairy products (SOLU-MEDROL® 40mg presentation includes lactose monohydrate, and may contain trace amounts of milk ingredients).
- •Patients 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.
- •Patients taking chronic medications that, when co-administered with methylprednisolone, are at increased risk for hypokalemia, altered drug levels, convulsions, or altered clearance: amphotericin B, diuretics, aminoglutethimide, macrolide antibiotics, anticholinesterases, antitubercular drugs, cholestyramine, cyclosporine, digitalis glycosides, estrogens (including oral contraceptives), hepatic enzyme inducers/inhibitors, and ketoconazole.
- •Patients have known contraindications for angiography. Patients with contrast allergy will be premedicated with diphenhydramine and steroids.
- •Patient has known active systemic infection or sepsis.
- •Patient has contraindication to anesthetic agents used for conscious sedation/monitored anesthesia care (MAC).
- •Concurrent participation in another research protocol for investigation of an experimental therapy.
- •Known or suspected inability to adhere to study protocol or protocol requirements, as per the discretion of the Investigator or treating provider.
研究组 & 干预措施
Treatment Cohort
Experimental
Intra-arterial 80mg lidocaine and 40mg methylprednisolone
干预措施: Lidocaine hydrochloride (Drug)
Treatment Cohort
Experimental
Intra-arterial 80mg lidocaine and 40mg methylprednisolone
干预措施: Methylprednisolone sodium succinate (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: From treatment to 12-week follow-up
Reported adverse events classified using MedDRA and CTCAE, including all events, treatment-related events, and any serious adverse event
次要结局
未报告次要终点
研究者
Daniel A Tonetti, MD
Director, Cerebrovascular Neurosurgery; Director, Acute Stroke and NeuroInterventional Suite
The Cooper Health System
研究点 (1)
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