Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 28
- 主要终点
- Change From Baseline in the Number of Monthly Migraine Days (MMDs)
研究概览
简要总结
Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines.
People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them.
When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.
详细描述
Participants will be randomly allocated to one of 3 treatment groups: Lu AG09222 high dose, Lu AG09222 low dose, or placebo, in a ratio of 2:1:2.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant has a diagnosis of migraine as defined by International Classification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening Visit.
- •The participant has a history of migraine onset at least 12 months prior to the Screening Visit.
- •The participant has a migraine onset at ≤50 years of age.
- •The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications.
排除标准
- •The participant has been previously dosed with an anti-pituitary adenylate cyclase-activating polypeptide (anti-PACAP) ligand-targeting antibody.
- •The participant has confounding and clinically significant pain syndromes.
- •The participant has a diagnosis of acute or active temporomandibular disorder.
- •The participant has a history or diagnosis of confounding headaches.
研究组 & 干预措施
Lu AG09222 High Dose
Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion.
干预措施: Lu AG09222 (Drug)
Lu AG09222 Low Dose
Participants will receive a single low dose of Lu AG09222 by IV infusion.
干预措施: Lu AG09222 (Drug)
Placebo
Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Number of Monthly Migraine Days (MMDs)
时间窗: Baseline, Week 4
The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that: * lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura * or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with aura), * or lasts ≥30 minutes and meets two of the three ICHD-3 criteria B (without the condition on 72 hours), C and D for migraine without aura (probable migraine), * or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication
次要结局
- Change From Baseline in the Number of Monthly Headache Days (MHDs)(Baseline, Week 4)
- Percentage of Participants With ≥50% Reduction From Baseline in MMDs(Baseline, Week 4)