NCT02344316已完成2 期
Melatonin for Migraine Prevention in Adolescents: A Pilot Remote Trial: "The BRAiN-M Study"
Amy Gelfand2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Number of Migraine/Migrainous Days Per 28 Day Period
研究概览
简要总结
Migraine in adolescents is common and effective and safe preventive treatments are needed. This is a pilot randomized controlled trial of melatonin versus placebo for migraine prevention in adolescents 12-17 years old.
详细描述
This is a pilot randomized controlled trial of melatonin vs. placebo for migraine prevention in adolescents 12-17 years old. The main goal of this pilot study is to estimate variance in the outcome measures to help with planning the future fully powered study. Participants will have an in person enrollment visit, followed by phone follow up visits and headache diary data collection via smart phone or internet.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-17 years and weight ≥40 kg, to allow consistent dosing for all participants of the melatonin dose that has been found to be effective in adults
- •Resides in California
- •Headache fulfills International Classification for Headache Disorders, Third Edition (beta version)33 criteria for episodic migraine (with or without aura) in adolescents
- •Has been experiencing episodic headaches for at least six months
- •Experiences between 6-14 days of migraine/migrainous headaches per month at baseline (cutoff for chronic migraine is ≥15 days/month)
- •Developmentally able to provide age-appropriate level of assent
- •Has a parent/guardian capable of giving written informed consent
- •Has daily access to a smartphone in order to be able to complete daily study procedures such as diary completion, and to receive text reminders
- •Subject and parent agree the adolescent will not use over-the-counter melatonin, or another migraine preventive medication, while participating in the study
- •Participant and at least one parent speak English
排除标准
- •Currently (or within the last 4 weeks) using any medication or device with migraine preventive properties: i.e. topiramate, amitriptyline, nortriptyline, propranolol, metoprolol, sodium valproate, gabapentin, flunarizine, methysergide, riboflavin, butterbur, coenzyme Q10, or the Cefaly TENS device. For onabotulinum toxin, they will have to have been off it for at least three months
- •Use of other sleep medication or sedating medication, such as benzodiazepines, trazodone, or melatonin receptor agonists
- •History of allergy or adverse event with previous use of exogenous melatonin
- •Previous ineffective trial of melatonin 3 mg nightly for migraine prevention, where the trial duration was at least three months in duration
- •Inability to swallow pills, if this inability persists after instruction on pill-swallowing techniques
- •History of epilepsy or seizure
- •Overuse of acute headache medications, wherein medication overuse is defined33 as ≥4 days per month of barbiturate containing compounds, ≥10 days per month of opioid containing compounds, or ≥10 days per month of triptans or ergot-containing compounds. Those using non-specific analgesics ≥15 days per month would also be excluded
- •Adolescent does not have the cognitive capacity to give verbal assent to participate, or the investigator thinks the adolescent does not have the cognitive capacity to complete the diary, even with parental assistance
- •For females: Pregnancy, lactating or planning to become pregnant during the study. For males: planning to father a child during the study
- •Abnormal neurologic examination findings
- •Serious medical illness of any kind; seriousness as judged by the investigator
- •The investigator does not think the participant can comply with study procedures, or does not think it is medically appropriate for the participant to be in the study
研究组 & 干预措施
Melatonin
Active Comparator
Group randomized to melatonin 3 mg orally nightly
干预措施: Melatonin (Drug)
Placebo
Placebo Comparator
Group randomized to placebo orally nightly
干预措施: Placebo (Other)
结局指标
主要结局
Number of Migraine/Migrainous Days Per 28 Day Period
时间窗: final 4 weeks of treatment
Number of Migraine/Migrainous Days Per 28 Day Period in melatonin group and placebo group as measured using an online/mobile device headache diary.
次要结局
- Number of Participants Recruited From Each Recruitment Strategy(During the enrollment period, approximately 1 year)
- Number of Minutes to Sleep Onset(16 weeks)
- Medication Adherence as Measured by Number of Openings Per Participant(during the "At Home Active Study Period" or Weeks 5-16)
- Headache Diary Compliance Rate(Weeks 12-16 of the study)
研究者
Amy Gelfand
Assistant Professor of Neurology
University of California, San Francisco
研究点 (2)
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