2024-510656-13-00招募中3 期
Interventional, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of IV eptinezumab in adolescents (12-17years) for the preventive treatment of chronic migraine.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 179
- 试验地点
- 22
- 主要终点
- "Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 "
研究概览
简要总结
To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.
研究设计
- 分配方式
- Randomized
- 主要目的
- Safety follow up period
- 盲法
- Double (Subject, Carer, Investigator, Monitor, Analyst)
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
- •During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
- •During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.
排除标准
- •The participant has previously been randomised in this study and exposed to eptinezumab.
- •The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit.
- •The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit.
- •The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example >60 minutes).
结局指标
主要结局
"Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 "
"Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 "
次要结局
- Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
- Percentage of Participants With Migraine on the Day After Dosing (Day 1)
- Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12
- Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
- Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
- Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
- Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12
- Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12
- Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12
- Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12
- Free Eptinezumab Plasma Concentration
- Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
- Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)
研究者
Global Trial Lead
Scientific
H. Lundbeck A/S
研究点 (22)
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