A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 56
- 主要终点
- Time to Absence of Most Bothersome Symptom (MBS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in participants experiencing an acute attack of migraine.
详细描述
This will be a parallel group, double-blind, randomized, placebo-controlled study assessing the efficacy of eptinezumab for acute migraine, defined as an active intercurrent migraine occurring in those participants who are candidates for preventive therapy. Participants will be randomized to receive a single dose of eptinezumab or placebo in a 1:1 ratio. The total study duration will be approximately 4 to 12 weeks, including up to an 8-week screening period and 4-week of safety follow-up, with clinic visits occurring on Screening, Day 0 (dosing day), and Week 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Greater than 1-year history of migraine, with or without aura, with onset of first migraine before age
- •Migraine on 4 to 15 days per month in the 3 months prior to screening.
- •Headache free for at least 24 hours prior to onset of a qualifying migraine.
排除标准
- •Unable to differentiate migraine from other headache or pain disorders.
- •Use of the following medication, for any indication, within the 24-hour period prior to dosing with study drug:
- •triptans, ergotamines and ergot-derivatives
- •analgesics (including but not limited to acetaminophen, tramadol, nonsteroidal anti-inflammatory drugs [NSAIDs], combination analgesics, caffeine-containing analgesics, and opioids/narcotics) and other acute migraine medication(s)
- •antiemetic medications (including but not limited to prochlorperazine, promethazine, droperidol, chlorpromazine, metoclopramide)
- •antihistamines
- •devices, neuromodulation, neurostimulation, or injectable therapy (trigger point injections, extracranial nerve blocks, facet joint injections, spinal manipulation)
- •Use of the following medication, for any indication, in each of the 3 months prior to screening:
- •opioids/narcotics or butalbital containing products (including combinations) on more than 4 days per month;
- •triptans, ergotamines, or combination analgesics for 10 or more days per month;
- •acetaminophen, aspirin or NSAIDs for 15 or more days per month (except if participant is taking 81 mg dose of aspirin for cardiac prophylaxis)
- •History or diagnosis of 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), ophthalmoplegic migraine and migraine with neurological accompaniments that are not typical of migraine aura (for example, diplopia, altered consciousness, or long duration).
- •Any changes to preventive migraine treatment(s) within 1 month prior to screening and up to treatment with the study drug (Day 0).
- •Any use of approved devices, neuromodulation, neurostimulation, or injectable therapy (trigger point injections, extracranial nerve blocks, facet joint injections) within the 24-hour period prior to treatment with study drug (Day 0).
- •Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 7 days prior to treatment with study drug (Day 0).
- •Any use of systemic corticosteroid for migraine or any other reason within 3 months prior to treatment with study drug (Day 0).
- •Evidence or medical history of clinically significant psychiatric diseases that are uncontrolled and/or untreated.
- •Receipt of any monoclonal antibody treatment, for migraine or any other indication, (within or outside a clinical study) within 6 months prior to screening.
研究组 & 干预措施
Eptinezumab
Participants will receive a single dose of eptinezumab 100 milligrams (mg) administered via intravenous (IV) infusion on Day 0.
干预措施: Eptinezumab (Drug)
Placebo
Participants will receive a single dose of placebo matching to eptinezumab administered via IV infusion on Day 0.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Absence of Most Bothersome Symptom (MBS)
时间窗: Up to 48 hours postdose
Time to absence of most bothersome symptom defined as the time that the participant reported absence of MBS (of nausea, photophobia, or phonophobia).
Time to Headache Pain Freedom
时间窗: Up to 48 hours postdose
Time to headache pain freedom defined as the time that the participant reported freedom of pain, meaning their headache pain had gone from moderate to severe at baseline to no pain.
次要结局
- Headache Pain Freedom at 4 Hours(4 hours)
- Absence of MBS at 4 Hours(4 hours)
- Headache Pain Freedom at 2 Hours(2 hours)
- Absence of MBS at 2 Hours(2 hours)
- Use of Rescue Medication Within the First 24 Hours(Up to 24 hours postdose)