Interventional, Open-label Trial, Investigating the Effectiveness of Eptinezumab in Participants With Migraine and Previous Inadequate Response to CGRP-targeting Therapies

H. Lundbeck A/S47 个研究点分布在 1 个国家目标入组 150 人2024年12月18日

适应症Migraine

干预措施Eptinezumab

概览

阶段: 4 期
干预措施: Eptinezumab
疾病 / 适应症: Migraine
发起方: H. Lundbeck A/S
入组人数: 150
试验地点: 47
主要终点: Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Scale
状态: 进行中（未招募）
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

The main goal of this trial is to learn whether eptinezumab improves migraine symptoms and quality of life of participants with migraine who did not perceive a sufficient improvement during previous treatment with therapies targeting calcitonin gene-related peptide (CGRP).

注册库

clinicaltrials.gov

开始日期

2024年12月18日

结束日期

2026年6月5日

最后更新

上个月

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

H. Lundbeck A/S

责任方

Sponsor

入排标准

入选标准

•The participant has a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) guidelines with a history of migraine of at least 12 months prior to the Screening Visit.
•The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
•The participant has documented evidence of recent inadequate response to either one anti-CGRP monoclonal antibody (mAb) (other than eptinezumab) or one gepant, indicated and used for migraine prevention.

排除标准

•The participant has taken more than 10 tablets of ubrogepant or more than 8 tablets of rimegepant per month as an acute migraine medication in the 1 month prior to the screening visit and during the 4-week baseline period.
•The participant has previously had an inadequate response to more than one CGRP-targeting therapy (anti-CGRP mAb or gepants), indicated for migraine prevention.
•The participant has a history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for \>5 years prior to the first dose of eptinezumab. Male participants with abnormal prostate-specific antigen levels according to national/local guideline may be enrolled in the trial provided they have been followed up, have been asymptomatic, and have had no treatment for prostate cancer. Participants under surveillance for a low and stable level of M-component are allowed.
•The participant has previously been treated with eptinezumab.
•Other protocol-defined inclusion and exclusion criteria apply.

研究组 & 干预措施

Eptinezumab

Participants will receive eptinezumab at Baseline (Day 1) and Week 12

干预措施: Eptinezumab

结局指标

主要结局

Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Scale

时间窗: Week 24

次要结局

Change from Baseline in Monthly Headache Days (MHDs)(Weeks 1-12 and 13-24)
Change from Baseline in Monthly Migraine Days (MMDs)(Weeks 1-12 and 13-24)
Change from Baseline in MMDs with Use of Acute Medication(Weeks 1-12 and 13-24)
Change from Baseline in Migraine Disability Assessment (MIDAS) Scores(Weeks 12 and 24)
Goal Attainment Scaling (GAS) Score(Weeks 12 and 24)
Change from Baseline in the Percentage of MMDs with Severe Pain Intensity(Weeks 1-12 and 13-24)
Number of Participants with Response of "Much Improved" or "Very Much Improved" on the PGIC Scale(Week 12)
PGIC Score(Weeks 12 and 24)
Number of Participants with GAS Score ≥50(Weeks 12 and 24)
Change from Baseline in Number of Good Days per Month(Weeks 12 and 24)
Change from Baseline in Migraine Clinical Outcome Assessment System-Cognition (MiCOAS-COG) Score(Weeks 12 and 24)
Number of Participants with Response of "Much Improved" or "Very Much Improved" in Brain Fog(Weeks 12 and 24)
Brain Fog Score(Weeks 12 and 24)
Number of Participants with Adverse Events (AEs)(Up to Week 26)
CGIC Score(Weeks 12 and 24)
Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Clinical Global Impression of Change (CGIC) Scale(Weeks 12 and 24)