Interventional, Open-label, Fixed-dose, Long-term Extension Study to Evaluate Safety of Eptinezumab as Preventive Treatment in Patients With Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 17
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
This study is an open label extension study, which means that the participants from the Lead-in Study 19140A (NCT04921384) can join this study, if they meet the study Eligibility Criteria, and continue to receive the study drug eptinezumab. The main goal of this study is to investigate long-term safety and tolerability of eptinezumab in Japanese migraine participants.
详细描述
The total study duration from the Baseline Visit to the Safety Follow-up Visit is approximately 68 weeks and includes an Open-Label Treatment Period (60 weeks) and a Safety Follow-up Period (8 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has completed the Primary Outcome Visit (Visit 5) of the lead-in Study 19140A immediately prior to enrolment into this study.
- •The participant is indicated for 60-week preventive treatment of chronic migraine with eptinezumab according to the clinical opinion of the investigator.
排除标准
- •The participant has a serious adverse event (SAE) or a moderate or severe ongoing AE from the Lead-In study considered a potential safety risk by the investigator.
- •The participant has a clinically relevant change in vital signs or electrocardiogram (ECG) from the Lead-In study considered a potential safety risk by the investigator.
- •The participant has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Eptinezumab
Participants will receive eptinezumab 100 milligrams (mg) at the Baseline visit (Week 0) and eptinezumab 100 mg or 300 mg (depending upon the treatment response) at Weeks 12, 24, 36, and 48 by intravenous (IV) infusions.
干预措施: Eptinezumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: From Baseline to Week 68
次要结局
- Change From Baseline in the Number of Monthly Migraine Days(Baseline, Week 60)
- Response: Number of Participants With ≥50% Reduction From Baseline in Monthly Migraine Days (MMDs)(Baseline to Week 60)
- Change From Baseline in the Headache Impact Test (HIT-6) Score(Baseline, Week 60)
- Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score(Baseline, Week 60)
- Patient Global Impression of Change (PGIC) Score(Baseline to Week 60)
- Change From Baseline in the Most Bothersome Symptom (MBS) Score(Baseline, Week 60)