CHOCOlate MeLatonin for AdolescenT MigrainE: The CHOCOLATE Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Mean Visual Analog Scale (VAS) Score
研究概览
简要总结
Existing treatments for acute migraine are not effective for all children and adolescents, and can cause side effects. Investigator propose a dose-finding study of melatonin for acute migraine treatment in children and adolescents to determine the best dose to bring forward in a future fully-powered efficacy trial.
详细描述
This pilot randomized trial is a dose-finding study to determine which dose of melatonin is most effective for treating acute migraine in children and adolescents who have episodic migraine. Investigator will identify the most effective dose to pull forward into a future fully-powered placebo-controlled efficacy study. If both doses are equally effective, Investigator will bring forward the best tolerated dose. If doses are equally well tolerated, Investigator will bring forward the lowest effective dose, as this will minimize cost to families should this treatment become widely adopted.
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
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet ICHD criteria for episodic migraine in children and adolescents, with at least 1 migraine attack per month on average.
- •Age 3-17 years
- •Dissatisfaction with previous acute treatments, for one or more of the following reasons: a) One or more previously tried acute medications have not been effective, or adequately effective, b) previously tried acute treatments have caused side effects, or C) patient/family would prefer a natural supplement for acute treatment over medication treatment
- •If of driving age, teen participant agrees not to drive for at least 8 hours after treating with melatonin.
排除标准
- •Allergy or intolerance to melatonin, or to chocolate.
- •Opioid or barbiturate overuse as defined in ICHD
- •Pregnant/lactating
研究组 & 干预措施
High-Dose Melatonin (mg)
melatonin 8mg (equal to or over 40kg) melatonin 4mg (under 40kg) Melatonin: melatonin
干预措施: Melatonin (Drug)
Low-Dose Melatonin (mg)
melatonin 2mg (equal to or over 40kg) melatonin 1mg (under 40kg) Melatonin: melatonin
干预措施: Melatonin (Drug)
结局指标
主要结局
Change in Mean Visual Analog Scale (VAS) Score
时间窗: Baseline (Time 0) and 2 hours
Visual Analog Scale (VAS) score ranges from 0-10, measured in cm, 0 indicating no pain and 10 indicating the worst pain.
次要结局
未报告次要终点
研究者
Amy Gelfand
Assistant Professor of Neurology
University of California, San Francisco