Eptinezumab as an Adjunct to Standard of Care for MIGRANE in an Acute EmeRgency Context (Migraine ERase Study)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Number of migraine days at week 1
研究概览
简要总结
The purpose of the study is to investigate how a medication called eptinezumab (Vyepti) given to patients in the Emergency Department (ED) might help prevent migraines from happening again. The results of this study may help inform better ways to manage patients with migraines in the ED.
Eptinezumab is currently approved by Health Canada for the preventive treatment of migraine, but its short-term effectiveness in the ED context is unknown. Unlike other migraine treatments used in the ED, eptinezumab can rapidly interrupt the migraine process, potentially also preventing migraine from coming back in the short term.
Most patients with a diagnosis of migraine have no access to preventative therapies. This study will be able to provide access to preventative therapy at the earliest stages of a migraine attack. Administering this medication in the ED may stop the attack more effectively compared to current therapies.
This study wants to see if eptinezumab could help stop migraines from coming back after individuals have been treated in the ED. The study will also explore whether eptinezumab could reduce how often individuals with migraine might need to come back to the ED, what other medications they might need alongside eptinezumab, and how they feel overall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults between the ages of 19-75 with a history of migraines, as established at the time of presentation to the ED or known from the patient's chart;
- •Presenting to the emergency department with a migraine that meets ICHD-3 migraine headache criteria;
- •Provided signed informed consent;
- •Sufficient literacy and cognitive capacity to understand and complete patient self-rated questionnaires in English.
排除标准
- •Secondary headaches caused by an injury or underlying illness, such as a concussion, bleeding in the brain, an infection or a brain tumor
- •Current or history of severe cardiovascular disease or renal dysfunction
- •A systemic condition in the stage of active treatment (vasculitis, etc.)
- •Pregnant or at risk of becoming pregnant (absent contraception)
- •Currently enrolled in another investigational drug trial
- •Dosed with eptinezumab within the past 3 months
- •Currently on anti-CGRP therapy with monoclonal antibodies
- •Currently involved in active litigation
- •Any other condition which, in the opinion of the Investigator, would exclude the participant due to reasons of safety or data integrity
- •Hypersensitivity to the active substance or to any of the excipients
研究组 & 干预措施
Standard of Care
SoC will be delivered at the discretion of the treating physician
干预措施: Standard of Care (Other)
Standard of Care + Eptinezumab
In addition to standard of care, participants randomized to the Standard of Care + Eptinezumab arm will receive a single infusion of eptinezumab (100mg/mL).
干预措施: Standard of Care (Other)
Standard of Care + Eptinezumab
In addition to standard of care, participants randomized to the Standard of Care + Eptinezumab arm will receive a single infusion of eptinezumab (100mg/mL).
干预措施: Eptinezumab (Biological)
结局指标
主要结局
Number of migraine days at week 1
时间窗: Baseline to Week 1
Number of migraine days at week 1, as reported in daily Headache Diary
次要结局
- Number of monthly headache days(Baseline to Month 3)
- Generalized Anxiety Disorder 7-item (GAD-7)(Baseline to Month 3)
- Patient Health Questionnaire (PHQ-9)(Baseline to Month 3)
- Readmission to the Emergency Department (ED)(Baseline to Month 3)
- Migraine recurrence(Baseline to Month 3)
- Sleep Quality(Baseline to Month 3)
- Headache Impact Test (HIT-6)(Baseline to Month 3)
- Patient Global Impression of Change (PGI-C)(Baseline to Month 3)
- Work Productivity and Activity Impairment (WPAI)(Baseline to Month 3)
研究者
Dr George Medvedev
Principal Investigator
HealthTech Connex Inc.