NCT06029153已完成不适用
Efficacy and Safety of Middle Meningeal Artery Embolization for Treatment of Intractable Migraine： a Single-arm, Self-control, Open-label, Single-center Trial
The Affiliated Hospital Of Guizhou Medical University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年6月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Headache attack frequency (times / month and Headache duration）
研究概览
简要总结
This study is a single-arm, self-controlled clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The main objectives of the study are to evaluate the effectiveness and safety of the treatment.
详细描述
This study is a single-arm, self-controlled, open-label, single-center clinical trial that explores and evaluates the efficacy of middle meningeal artery embolization with coil in improving migraine symptoms. The inclusion criteria consist of patients with or without aura migraines, who have experienced persistent, chronic migraines for at least 3 months before screening, and have shown resistance to at least two or more drug treatments, with unsatisfactory therapeutic effects, intolerable side effects, or contraindications. The main objectives of the study are to evaluate the effectiveness and safety of the treatment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary written informed consent.
- •Age 18~80 years old (inclusive), regardless of gender.
- •Migraine was diagnosed by clinicians, according to The International Classification of Headache Disorders,3rd Edition
- •Patients with intractable migraine or refractory headache with migraine duration of more than 3 months and recurring migraine in the past 90 days before screening.
- •Patients who take two or more drugs are not satisfied with the therapeutic effect, the side effects of drug treatment are difficult to tolerate or have contraindications.
- •Headache frequency should be confirmed within 30 days before screening.
- •Patients with good compliance, willing and able to follow the requirements of treatment and follow-up observation.
排除标准
- •Patients with cervical spondylosis and secondary headaches such as otogenic, nasal, and odontogenic patients with a history of trigeminal autonomic headache, other definite causes of headache, or secondary headache.
- •Patients without suitable vascular access.
- •Patients scheduled for surgery within 90 days.
- •The life expectancy of patients is less than 12 months.
- •History of contrast agent allergy.
- •Lactating or pregnant women, or patients with a fertility plan within 1 year.
- •The clinical status of the patient was extremely poor, with an mRS Score ≥
- •Participants who had participated in clinical studies of other drugs or medical devices before enrollment and did not meet the primary study endpoint time limit.
- •The investigator judged that the patient had poor compliance and could not complete the study as required.
- •The patient had a clear history of allergies to embolic materials such as Nitinol alloy, cobalt-based alloy, and platinum-tungsten alloy.
- •Patient was allergic to the contrast agent.
- •Patients with other diseases limit their participation in the study, cannot follow up, or affect the scientific integrity of the study.
- •Patients have clotting disorders or are on anticoagulant therapy.
- •Patients have a history of opioid addiction.
- •Researchers believe that patients who are not suitable to participate in this trial.
结局指标
主要结局
Headache attack frequency (times / month and Headache duration）
时间窗: At baseline, 90 days after treatment
Record of headache attack frequency (times / month and Headache duration）
次要结局
- Headache aura(nausea,photophobia,phonophobia) frequency(At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment)
- Headache attack frequency (days / month)(At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment)
- Headache Impact(At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment)
- Days of medication in acute phase and dosage(At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment)
- Severity of headache:Visual Analogue Scale(At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment)
- Severity of headache:Numerical Rating Scale(At baseline,36 hours,day of discharge,30 days, 60 days, 90 days, 180 days, 1 year after treatment)
- Migraine Disability Assessment(At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment)
- Hospital Anxiety and Depression(At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment)
- Migraine-Specific Questionnaire(At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment)
- Clinical Global Impression(At baseline,30 days, 60 days, 90 days, 180 days, 1 year after treatment)
研究者
Zeguang Ren
Dr.
The Affiliated Hospital Of Guizhou Medical University
研究点 (1)
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