NCT04603976Unknown4 期
Registry for Migraine - Clinical Core
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Headache Diary
研究概览
简要总结
This study aims to investigate the effect of erenumab on efficacy outcomes, tolerability outcomes, and patient-reported outcomes in individuals with migraine. Furthermore, the study aims to identify clinical predictors of erenumab response.
详细描述
Migraine is a prevalent neurological disorder and a leading cause of years lived with disability worldwide. As of recent, therapies targeting calcitonin gene-related peptide (e.g. erenumab) have been approved for the preventive treatment of migraine. This study aims to investigate the effect of erenumab on efficacy outcomes, tolerability outcomes, and patient-reported outcomes in individuals with migraine. Furthermore, the study aims to identify clinical predictors of erenumab response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent prior to initiation of any study-specific activities/procedures
- •Age greater than or equal to 18 years upon entry into screening
- •History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the International Headache Society (IHS) Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2018) based on medical records and/or patient self report
- •Greater than or equal to 4 headache days that meet criteria as migraine days per month on average across the 3 months before screening after baseline period
- •Must have demonstrated greater than or equal to 75% compliance in headache diiary usage during baseline period
排除标准
- •Subjects are excluded from the study if any of the following criteria apply:
- •Disease Related
- •Greater than 50 years of age at migraine onset
- •History of cluster headache or hemiplegic migraine headache
- •Inability to differentiate between migraine from other headaches
- •The subject is at risk of self-harm or harm to others as evidenced by past suicidal behaviour
- •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 would pose a risk to subject safety or interfere with the study evaluation, procedures or completion Prior/Concomitant Therapy
- •Previously received erenumab (Aimovig®)
- •Received an anti-CGRP monoclonal antibody within 3 months prior to the start of the baseline period Prior/Concurrent Clinical Study Experience
- •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.
- •Other Exclusions
- •Female subjects of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a urine pregnancy test.
- •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.
- •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.
- •Evidence of current pregnancy or breastfeeding per subject self-report or medical records
- •Subject has known sensitivity to any of the products or components to be administered during dosing
- •Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge
研究组 & 干预措施
Single-Arm
Experimental
Erenumab packed in a SureClick® Autoinjector Pen (AI)
干预措施: Erenumab (Drug)
结局指标
主要结局
Headache Diary
时间窗: Baseline Phase (Day -28 to Day 1) to Week 24
Headache diary with daily entries to record migraine-related data.
次要结局
- Headache Diary(Baseline Phase (Day -28 to Day 1) to Week 48)
- Semi-Structured Interview(Screening Visit (Day -28))
- Headache Impact Test (HIT-6)(Baseline Phase (Day -28 to Day 1) to Week 48)
- Migraine Disability Assessment Test (MIDAS)(Baseline Phase (Day -28 to Day 1) to Week 48)
- Hospital Anxiety and Depression Scale (HADS)(Baseline Phase (Day -28 to Day 1) to Week 48)
- Pittsburgh Sleep Quality Index (PSQI)(Baseline Phase (Day -28 to Day 1) to Week 48)
- 12-item Allodynia Symptom Checklist (ASC-12)(Baseline Phase (Day -28 to Day 1) to Week 48)
- WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)(Baseline Phase (Day -28 to Day 1) to Week 48)
- Neck Disability Index (NDI)(Baseline Phase (Day -28 to Day 1) to Week 48)
- Low Back Pain Disability Questionnaire(Baseline Phase (Day -28 to Day 1) to Week 48)
研究者
Messoud Ashina
Professor of Neurology
Danish Headache Center
研究点 (1)
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