EUCTR2006-000210-21-DK进行中（未招募）不适用
A single centre, double-blind, randomised, placebo controlled cross-over study to evaluate the efficacy and tolerability of tonabersat in the prophylaxis of migraine in patients presenting with migraine with aura
Prof Jes Olesen0 个研究点目标入组 34 人开始时间: 2006年3月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 34
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 with an established history of migraine of at least one year meeting the diagnostic criteria of the International Classification of Headache Disorders – Edition 2 (Appendix 2) and who experience at least one aura a month.
- •Male or female patients between 18-65 years of age; women of child bearing potential must be using a reliable form of contraception for at least 3 months prior to enrolment.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
- •Patients experiencing headache other than migraine or tension headache
- •Overuse of acute migraine treatments defined as more than 14 daily doses per month with analgesics or more than 9 daily doses per month of ergots or triptans within the last two months
- •Migraine prophylactic treatment within two months prior to entry to the trial
- •Patients taking any of the following medications for migraine: beta-blockers, tricyclic antidepressants (during the last 2 months), antiepileptic dugs (during the last 2 months), calcium channel blockers, monoamine oxidase inhibitors, daily NSAIDs, daily paracetamol, high dose magnesium supplements (600mg/day). Parenteral administration of botulinum toxin is also excluded. These drugs are permitted when given for diseases other than migraine provided that, in the opinion of the investigator the dose can be kept constant throughout the trial.
- •Patients who, in the opinion of the investigator, have significant cerebrovascular disease e.g. transient ischaemic attacks, stroke
- •Patients who, in the opinion of the investigator, have clinically significant cardiovascular disease
- •Patients suffering from a current clinical diagnosis of a major depressive disorder or schizophrenia
- •Patients with renal dysfunction , defined as a serum creatinine of greater than 125% of the upper limit of normal for their age group
- •Patients with hepatic dysfunction defined as a liver function test (AST, ALT, alkaline phosphatase, bilirubin) of greater than twice the upper limit of normal for their age group
- •Women who are pregnant or breast feeding
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