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临床试验/EUCTR2020-000661-16-DK
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.

研究者

发起方
Rigshospitalet Glostrup

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