Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Headache Diary (Baseline Phase and Treatment Phase)
研究概览
简要总结
To explore the relationship between clinical response to erenumab and response to intravenous infusion of calcitonin gene-related peptide in individuals with migraine.
详细描述
This is a single-center, non-randomized, single-arm, open-label study, in which adults with episodic or chronic migraine will receive intravenous infusion with calcitonin gene-related peptide and subsequently be treated with erenumab. The study will consist of the following elements:
- Provocation Phase (1 experimental day with intravenous infusion of calcitonin gene-related peptide)
- Screening/Baseline Phase (4 weeks)
- Open-Label Treatment Phase (24 weeks)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of age upon entry into screening
- •History of migraine with or without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria
- •≥ 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening
- •Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- •Must have demonstrated greater than or equal to 75% compliance in Headache Diary usage during the 4-week run-period prior to Day 1 of the open-label treatment phase.
排除标准
- •> 50 years of age at migraine onset
- •History of cluster headache or hemiplegic migraine
- •Inability to differentiate migraine from other headaches
- •The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- •History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
- •Previously received erenumab (Aimovig)
- •Received anti-CGRP monoclonal antibody within 3 months prior to the CGRP-infusion
- •Currently receiving treatment in another investigational device or drug study, or less than 30 days or 5 half-lives since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
- •Female subjects of childbearing potential with a positive pregnancy test during any study visit
- •Female subject is pregnant or breastfeeding or planning to become pregnant during the study
- •Evidence of current pregnancy or breastfeeding
- •Female subject of childbearing potential unwilling to use an acceptable method of effective contraception
- •Hypertension on the experimental day defined as systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 100mmHg
- •Hypotension on the experimental day defined as systolic blood pressure < 90mmHg or diastolic blood pressure < 50mmHg
- •Any headache (including migraine) within 24 hours prior to the start of the CGRP-infusion
- •Intake of any analgesics or migraine-specific medications within 24 hours prior to the start of the CGRP-infusion
- •Subject likely to not be available to complete all protocol-required study visits or procedures, and/or comply with all required study procedures to the best of the subject and study investigator's knowledge
研究组 & 干预措施
Single-Arm
Provocation Phase: Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.
Open-Label Treatment Phase: Erenumab packed in a SureClick® Autoinjector Pen (AI)
干预措施: Calcitonin Gene-Related Peptide (Drug)
Single-Arm
Provocation Phase: Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.
Open-Label Treatment Phase: Erenumab packed in a SureClick® Autoinjector Pen (AI)
干预措施: Erenumab (Drug)
结局指标
主要结局
Headache Diary (Baseline Phase and Treatment Phase)
时间窗: Baseline Phase (Day -28 to Day 1) to Week 24
Headache diary with daily entries to record migraine-related data (e.g. migraine days, headache days, number of days with use of acute migraine medication, number of days with aura).
次要结局
- Headache Diary (Provocation Phase)(Provocation Phase (12 Hours))
- Semi-Structured Interview(1 Hour)
研究者
Messoud Ashina, MD
Professor of Neurology
Danish Headache Center