EUCTR2019-002331-28-IS进行中（未招募）1 期
Biomarker and Genetic Predictors of Erenumab Treatment Response, a Phase 4 Investigational Open-label Study (INTERROGATE) - INTERROGATE
Amgen Inc.0 个研究点目标入组 1,406 人开始时间: 2024年3月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,406
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Before baseline period
- •101 Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- •102 Age = 18 years upon entry into screening.
- •103 History of migraine (with or without aura) for = 12 months before screening according to the International Headache Society (IHS) Classification ICDH-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self-report
- •104 = 4 headache days that meet criteria as migraine day per month on average across the 3 months before screening
- •After baseline period
- •105 Must have demonstrated = 75% compliance in eDiary usage during baseline period
- •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 2000
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •201 > 50 years of age at migraine onset
- •202 History of cluster headache or hemiplegic migraine headache
- •203 Inability to differentiate between migraine from other headaches
- •204 The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
- •205 History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •206 Previously received erenumab (Aimovig)
- •207 Received an anti-CGRP monoclonal antibody within 3 months prior to the start of the baseline period
- •208 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.
- •209 Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
- •210 Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 16 weeks after the last dose of investigational product.
- •211 Female subjects of childbearing potential unwilling to use 1 acceptable method of effective contraception during treatment and for an additional 16 weeks after the last dose of investigational product.
- •212 Evidence of current pregnancy or breastfeeding per subject self-report or medical record
- •213 Subject has known sensitivity to any of the products or components to be administered during dosing.
- •241 Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator’s knowledge.
研究者
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