Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine: An Open-Label Randomized Trial.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Pain Perception
研究概览
简要总结
The objective of this study is to compare clinical efficacy and tolerability of valproic acid (VPA) therapy versus dihydroergotamine (DHE) as abortive therapy in pediatric migraine.
详细描述
The purpose of this study is to compare valproic acid (VPA) and dihydroergotamine (DHE) alone and sequentially in the treatment of pediatric migraines.
Inpatient pediatric migraine patients (based on International Classification of Headache Disorders, ICHD-II criteria) or those admitted to the University of Kentucky emergency department will receive standard of care acute headache management as per AAP/AAN guidelines. Those who fail to respond will be considered for further eligibility. Informed consent/assent will be obtained from the patients, parents or legal guardian.
Baseline labs will be collected prior to the start of the study.
- Complete Blood Count (CBC)
- Comprehensive Metabolic Panel (CMP)
- Prothrombin Time/Activated Partial Thromboplastin Time/International Normalized Ratio (PT/APTT/INR)
- Magnesium and phosphorous
Patients will initially be randomized into two groups (VPA or DHE) and treated for 24 hours. Those patients whose migraines resolve will end the study at 24 hours. Patients who are refractory to treatment will switch interventions and continue treatment for an additional 24 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute migraine as per ICHD-II criteria
- •pediatric (age 10-18)
排除标准
- •For Valproic Acid (VPA)
- •Pregnancy
- •Liver disease (Acute or Chronic)
- •Urea Cycle Disorder
- •Mitochondrial Disease
- •For Dihydroergotamine (DHE)
- •Pregnancy
- •Peripheral vascular disease, coronary heart disease
- •History of cerebrovascular event
- •Severe or poorly controlled hypertension
- •Impaired liver or renal function
- •Triptan given in last 24 hours
- •Hemiplegic migraine
研究组 & 干预措施
Valproic Acid
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
干预措施: Valproic Acid (VPA) (Drug)
Dihydroergotamine
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.
干预措施: Dihydroergotamine (DHE) (Drug)
Cross-Over to Dihydroergotamine
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.
干预措施: Valproic Acid (VPA) (Drug)
Cross-Over to Dihydroergotamine
An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels. Patients who do not respond to VPA after 24 hours will be given Dihydroergotamine (DHE) for the next 24 hours. Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours.
干预措施: Dihydroergotamine (DHE) (Drug)
Cross-Over to Valproic Acid
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
干预措施: Valproic Acid (VPA) (Drug)
Cross-Over to Valproic Acid
Dihydroergotamine (DHE) will be given as weight-based dosing, with no single dose >1mg and not exceeding 3mg over 24 hours. Patients who do not respond to DHE after 24 hours will be given Valproic Acid (VPA) for the next 24 hours. An initial dose of Valproic Acid (VPA) will be given IV at 20mg/kg, followed by continuous infusion of 1mg/kg/hour for 24 hours. Serum levels of VPA will be checked at 4 and 24 hours, with additional timepoints possible at 8 and 12 hours based on drug levels.
干预措施: Dihydroergotamine (DHE) (Drug)
结局指标
主要结局
Change in Pain Perception
时间窗: Baseline to 24 hours
Change in pain perception measured by the 10-point visual analogue scale (VAS), where 0 is "no pain" and 10 is "pain as bad as it could be."
次要结局
- Percentage of Participants With Presence of Nausea(Baseline, 4, 8, 12 and 24 hours)
- Percentage of Participants With Presence of Photophobia(Baseline, 4, 8, 12 and 24 hours)
- Percentage of Participants With Presence of Phonophobia(Baseline, 4, 8, 12 and 24 hours)
研究者
Kimberly S Jones
Assistant Professor of Neurology and Pediatrics
University of Kentucky