EUCTR2010-019947-21-ES进行中（未招募）不适用
Phase III study, multicenter, randomized, double-blind, parallel group measuring the efficacy and safety of flunarizine in the prevention of migraine in the pediatric population. - MIGRAPED
CAIBER0 个研究点开始时间: 2011年11月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Patients aged from 7 to 14 years attended at Neuropediatrics outpatient clinic of the participating centers and diagnosed with migraine according to IHS criteria.
- •-Patients who had at least two migraine episodes per week in the last month.
- •-Informed consent signed (parent / legal representative and the patient in case of children aged 12-14 years).
- •-Assent of the child in case of children aged 7-11 years
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 180
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Previous treatment with flunarizine.
- •·Previous participation in other migraine clinical trials.
- •·Patients with lactose intolerance, since it is one of the excipients contained in both the drug and placebo.
- •·Contraindication of flunarizine according to study data sheet (eg, extrapyramidal symptoms, depressive syndrome), or according to the physician discretion.
- •·Patients taking hypnotics or sedatives, or who consume alcohol on a regular basis, as flunarizine may enhance their sedative effect.
- •·Patients treated with the following medication that cannot be suspended during the conduct of the trial (for having an indication other than migraine): calcium antagonists, beta-blockers, tricyclic antidepressants, and inhibitors of serotonin re-uptake, some antiepileptics (topiramate, zonisamide, valproic acid), or antiserotoninergic.
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