Clinical Predictors of Propranolol Responsiveness in Pediatric Migraine: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score
研究概览
简要总结
This prospective, controlled clinical trial was conducted to evaluate the effectiveness of propranolol compared with structured behavioral therapy in pediatric patients diagnosed with primary migraine according to ICHD-3 criteria. A total of 178 children aged 6 to 16 years were enrolled between January 2021 and December 2023 at a tertiary pediatric neurology center.
Participants were allocated into two groups based on baseline Pediatric Migraine Disability Assessment (PedMIDAS) scores: Group 1 received standardized behavioral therapy, while Group 2 received propranolol at doses ranging from 1-3 mg/kg/day for 12 weeks. Primary outcomes included changes in PedMIDAS and Visual Analog Scale (VAS) scores. Secondary analyses investigated clinical and biochemical predictors of propranolol responsiveness, including benign paroxysmal vertigo, essential tremor, anxiety, vitamin D status, and vitamin B12 levels.
The study aims to provide evidence for a more personalized approach to migraine prophylaxis in children by integrating clinical, psychiatric, and nutritional predictors of treatment response.
详细描述
Migraine is among the most common neurological disorders in children and adolescents, often leading to significant disability, reduced school performance, and impaired quality of life. Although propranolol is frequently prescribed for pediatric migraine prophylaxis, previous studies have reported heterogeneous outcomes, and clinical predictors of treatment response remain unclear.
This prospective, controlled clinical trial was designed to assess the comparative effectiveness of propranolol and structured behavioral therapy in pediatric migraine patients and to identify predictors of response to propranolol. A total of 178 children, aged 6-16 years, diagnosed with primary migraine according to ICHD-3 criteria, were consecutively recruited at a tertiary pediatric neurology center between January 2021 and December 2023.
Participants were allocated into two groups based on baseline Pediatric Migraine Disability Assessment (PedMIDAS) scores:
Group 1 (n = 88) received structured behavioral therapy, including patient education, lifestyle guidance, and headache diary maintenance.
Group 2 (n = 90) received oral propranolol at doses of 1-3 mg/kg/day for 12 weeks, with adherence monitored through logs and follow-up calls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary migraine (with or without aura) according to ICHD-3 criteria
- •Age between 6 and 16 years
- •Minimum of 4 migraine attacks per month
- •No history of prophylactic migraine therapy within the last 3 months
- •Written informed consent obtained from parents or legal guardians
排除标准
- •Secondary headaches due to underlying pathologies (e.g., tumors, infections, vascular malformations)
- •Chronic systemic or psychiatric disorders (e.g., epilepsy, major depression)
- •Contraindications to propranolol (e.g., asthma, cardiac conduction defects)
- •Incomplete clinical data or loss to follow-up
研究组 & 干预措施
Structured Behavioral Therapy
Participants received structured behavioral therapy including patient education, lifestyle guidance, and maintenance of a headache diary, without pharmacological prophylaxis.
干预措施: Structured Behavioral Therapy (Behavioral)
Propranolol
Participants received oral propranolol at 1-3 mg/kg/day in two divided doses for 12 weeks. Dose titration was performed based on clinical response and tolerance.
干预措施: Propranolol (Drug)
结局指标
主要结局
Change in Pediatric Migraine Disability Assessment (PedMIDAS) Score
时间窗: Baseline and Week 12
Change in PedMIDAS score from baseline to 12 weeks, assessing migraine-related disability in pediatric patients. The PedMIDAS score ranges from 0 to 240, with higher scores indicating greater migraine-related disability. Lower scores reflect less disability and therefore a better outcome.
Change in Visual Analog Scale (VAS) Pain Score
时间窗: Baseline and Week 12
Change in VAS pain intensity score from baseline to 12 weeks, evaluating migraine pain severity. The VAS score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse pain severity, while lower scores indicate improvement.
次要结局
- Responder Rate(Week 12)
研究者
Özge BAYKAN ÇOPUROĞLU
Asst. Prof.
Kayseri University