Molecular Stratification of Signaling Pathways Underlying Migraine Pathophysiology.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- A subjective report of a migraine attack
研究概览
简要总结
To investigate whether administration of calcitonin gene-related peptide (CGRP) binding monoclonal antibodies eptinezumab prevents pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) induced migraine attacks in migraine without aura patients.
详细描述
The aim of the present study is to investigate whether
- CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in migraine without aura patients.
Clinical and basic research have established calcitonin gene-related peptide (CGRP) as central molecule in migraine pathophysiology, yet existing CGRP antagonizing therapies such as the CGRP and CGRP receptor binding monoclonal antibodies are only effective in 50-60% of migraine patients. PACAP-38 and CGRP colocalize in the trigeminovascular system, and both activate adenylate cyclase upon receptor binding which causes increased formation of cyclic AMP (cAMP). It is unknown if CGRP and PACAP-38 signaling pathways differ sufficiently for PACAP-38 to be an alternative treatment target to CGRP. Whether administration of CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in migraine without aura patients is yet to be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy volunteers of both sexes.
- •18-60 years.
- •50-100 kg.
- •Women of childbearing potential must use adequate contraception
- •History of migraine without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria.
- •No migraine preventive treatment.
排除标准
- •A history of serious somatic disease
- •> 50 years of age at migraine onset.
- •History of any other primary headaches disorder (except ≤ 5 monthly days with tension- type headache).
- •Daily intake of any medication except contraceptives
研究组 & 干预措施
Eptinezumab and PACAP-38
The participants will receive an intravenous infusion of eptinezumab (300 mg) over 30 minutes followed (2 hours later) by an intravenous infusion of PACAP-38 (10 pmol/kg/min) over 20 minutes.
干预措施: Eptinezumab (Drug)
Eptinezumab and PACAP-38
The participants will receive an intravenous infusion of eptinezumab (300 mg) over 30 minutes followed (2 hours later) by an intravenous infusion of PACAP-38 (10 pmol/kg/min) over 20 minutes.
干预措施: PACAP-38 (Drug)
Placebo and PACAP-38
The participants will receive an intravenous infusion of placebo (saline) over 30 minutes followed (2 hours later) by an intravenous infusion of PACAP-38 (10 pmol/kg/min) over 20 minutes.
干预措施: PACAP-38 (Drug)
结局指标
主要结局
A subjective report of a migraine attack
时间窗: Time of reporting migraine attack is from the baseline to 24 hours after eptinezumab/placebo administration.
The participants report whether they feel a migraine attack (Yes or no).
次要结局
- Headache(Time of headache measurements is from from the baseline to 24 hours eptinezumab/placebo administration.)
- Changes in the superficial temporal artery (STA).(Time of headache measurements is from from the baseline to 24 hours eptinezumab/placebo administration.)
研究者
Mohammad Al-Mahdi Al-Karagholi
Study investigator
Danish Headache Center