EUCTR2020-000661-16-DK进行中(未招募)1 期
The effect of anti-calcitonin gene-related peptide (CGRP) receptor antibodies on the headache inducing properties of CGRP and cilostazol in migraine patients
Rigshospitalet Glostrup0 个研究点目标入组 72 人开始时间: 2020年3月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 72
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
- •(1) Patients with migraine with or without aura according to ICHD-3 of both sexes with a frequency of =4 migraine days per month
- •(2) 18-60 years old
- •(3) 50-100 kg weight
- •(4) Participants of childbearing potential must use safe contraception (birth control) or be sexually abstinent
- •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 72
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •(1) Any other primary headache disorder according to ICHD-3 except for tension-type headache
- •(2) Any secondary headache disorder according to ICHD-3
- •(3) Migraine attack during the preceding 48 hours on provocation day(s)
- •(4) Headache during the preceding 24 hours on provocation day(s)
- •(4) Treatment with mAbs or participation in clinical trials with mAbs during the preceding year.
- •(5) Daily consumption of any other drug/medication than oral contraception (birth control)
- •(6) Consumption of any other drug/medication later than four times the plasma half-time of the drug on provocation day except for oral contraception.
- •(7) Pregnant or active breastfeeding participants.
- •(8) Any cardiovascular diseases including cerebrovascular disorders.
- •(9) Information in patient history or during physical examination indicating psychiatric disorders or substance abuse.
- •(10) Information in patient history or during physical examination that the screening physician deems relevant for participation in the study.
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