2024-518943-38-00招募中3 期
KETALGIA : Evaluation of the effectiveness of a ketamine infusion combined with magnesium sulfate in the treatment of chronic refractory cluster headache
University Hospital Of Clermont-Ferrand14 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月3日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 14
- 主要终点
- Change in weekly frequency of crisis over the period D7-D13 compared to the pre-treatment period
研究概览
简要总结
Evaluate the efficacy of a single infusion of ketamine combined with magnesium sulfate compared to a control group receiving hydroxyzine (active placebo)
研究设计
- 分配方式
- Randomized
- 主要目的
- Allocation du traitement
- 盲法
- Double (Monitor, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Diagnosis of chronic cluster headache according to ICHD-3 criteria
- •Presence of at least 2 crises/24 hours on average during the 14 days preceding the ketamine infusion
- •Insufficient effectiveness, intolerance or contraindication to the use of the 3 major treatments for the management of cluster headaches: verapamil, lithium and corticosteroids (oral or suboccipital injections)
- •informed consent
排除标准
- •Pregnant or breastfeeding woman
- •Contraindication to the use of ketamine
- •Use of ketamine in the year preceding the study
- •Severe renal failure
- •Severe liver failure
- •Implementation or modification of an analgesic treatment (background treatments) in the 7 days preceding the infusion
- •Patient under legal protection measure
- •Addictive behaviors
- •Corrected QT > 450ms
结局指标
主要结局
Change in weekly frequency of crisis over the period D7-D13 compared to the pre-treatment period
Change in weekly frequency of crisis over the period D7-D13 compared to the pre-treatment period
次要结局
- Change in weekly frequency of crisis over the period D14-D20, D21-D27, D28-D34 compared to the pre-treatment period
- The proportion of responders at 30%, 50% and 75% each week post-infusion
- Response to treatment according to initial serum magnesium
- The weekly frequency and intensity of crisis between the 7 days preceding the infusion and each week post infusion
- Crisis treatments intake
- Anxiety and depression scoring (HAD)
- The PGIC scoring for the overall clinical evaluation on D15 and D90
- The proportion of patients requiring additional treatment on D15
- Direct medical costs
- Evaluation of adverse effects
- Evaluation of blinding quality
研究者
Lise Laclautre
Scientific
University Hospital Of Clermont-Ferrand
研究点 (14)
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