Botox Injection in Treatment of Chronic Migraine
Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Migraine. Safety Issues.
Chronic migraine is in many cases a most disabling condition. Chronic migraine is defined as headaches for at least 15 days per month, of which 8 days have typical migraine features. In many cases, oral drug treatment has little effect.
The parasympathetic nervous system acting through the sphenopalatine ganglion may be involved in several primary headaches, including migraine, by facilitating release of inflammatory substances in cerebral vessels. Botulinum toxin type A (BTA) inhibits excretion of acetylcholine resulting in blocking of nerve signals in the sphenopalatine ganglion.
The purpose of the present study is to evaluate a new technique with injection of BTA using an minimal invasive image guided procedure, for blocking of the sphenopalatine ganglion. The goal is to relieve the migraine symptoms and develop an alternate treatment for cases where oral drug treatments fail.
The main objective of the project is to determine the safety of this method of BTA injection in the area of the sphenopalatine ganglion by detecting adverse events. Secondary objectives are to measure changes in headache attack parameters with this novel method.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Trondheim、挪威
- Department of Neuroscience, Norwegian University of Science and Technology
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Informed and written consent
- Chronic migraine with or without aura defined in International Classification of Headache Disorders (ICHD)-3 criteria
- Failed at least 3 oral migraine prophylactic treatments
- Duration of migraine at least 1 year before inclusion
- Start of migraine before participant turned 50 years
- Participant can make a distinction between migraine and other types of headache
Exclusion Criteria:
- If the criteria for medication-overuse headache (MOH) is fulfilled
- Heart or lung disease
- Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection
- Psychiatric illness that hinders participation in the study
- Known pregnancy or breast feeding
- Inadequate use of contraceptives
- Overuse or abuse of opioids
- Abuse of medications, narcotics or alcohol
- Anomalies which hinder or impede the used method of injection
- Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication
- Treatment with medication that can interact with botulinum toxin type A
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Botulinum Toxin
The patients will be injected with 25 IU of Botulinum Toxin Type A towards both the right and left sphenopalatine ganglion, a total of 50 IU.
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of adverse events and number of participants with adverse events
大体时间：For the follow-up period of 3 months
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Number of adverse events and number of participants with adverse events after BTA injection in the area of the sphenopalatine ganglion and severity of adverse events by the method used.
Registration of any adverse events categorized by probable relationship to drug or the procedure.
Data obtained from the headache diaries as well as open questions during consultations.
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For the follow-up period of 3 months
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Number of headache days with moderate or severe intensity
大体时间：5-8 weeks
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measured from week 5 to week 8, in total during 4 weeks
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5-8 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of reponders
大体时间：12 weeks
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response is defined as ≥ 50% reduction in number of headache days with moderate or severe intensity per 4 weeks (week 1-4, week 5-8, week 9-12)
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12 weeks
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Days with moderate or severe headache per 4 weeks
大体时间：12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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Days without headache per 4 weeks
大体时间：12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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Hours with headache of moderate or severe headache per 4 weeks
大体时间：12 weeks
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week 1-4, week 5-8, week 9-12
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12 weeks
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合作者和调查者
调查人员
- 首席研究员：Erling A Tronvik, PhD, MD、Norwegian University of Science and Technology
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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