A Phase 3, 12-Month, Open-Label Study of Lasmiditan in Pediatric Patients With Migraine - PIONEER-PEDS2
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 558
- 试验地点
- 225
- 主要终点
- Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
The reason for this 12-month, open-label study is to see if the study drug lasmiditan is safe and effective for the intermittent acute treatment of migraine in children aged 6 to 17. The study will last about 12 months and may include up to 7 visits.
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
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have completed study H8H-MC-LAHX (NCT03988088) or study H8H-MC-LAHV (NCT number to be determined)
- •Participants must weigh at least 15 kilograms (kg)
排除标准
- •Participants must not be pregnant or nursing
- •Participants must not have any acute, serious, or unstable medical condition
- •Participants must not be actively suicidal or at significant risk for suicide, in the opinion of the investigator
研究组 & 干预措施
50/100/200 mg Lasmiditan
- Participants received lasmiditan (100 mg for body weight ≤40 kg or 200 mg for body weight >40 kg) administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
- One dose reduction due to tolerability concerns (to 50 mg for body weight ≤40 kg or 100 mg for body weight >40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
干预措施: Lasmiditan (Drug)
25/50/100 mg Lasmiditan
- Participants received lasmiditan [50 milligram (mg) for body weight less than or equal to 40 kilogram (≤ 40 kg) or 100 mg for body weight greater than (>)40 kg] administered orally as a single dose per migraine attack (maximum 1 dose per 24 hours) during a 12-month treatment period, with treatment of up to 8 migraine attacks per month.
- One dose reduction due to tolerability concerns (to 25 mg for body weight ≤40 kg or 50 mg for body weight >40 kg) was permitted after treatment of at least 3 migraine attacks at the randomized dose.
干预措施: Lasmiditan (Drug)
结局指标
主要结局
Number of Participants With at Least One Treatment Emergent Adverse Events (TEAEs)
时间窗: Baseline up to 12-month treatment period (Up to 12 Months)
An AE with an onset on or within 48 hours after a dose of study drug, or an event that worsened in intensity within 48 hours of a dose of study drug was considered a treatment-emergent adverse event (TEAE). A summary of serious adverse events (SAEs) and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module.
Number of Participants With Discontinuations Due to Adverse Events (AEs)
时间窗: Baseline up to 12-month treatment period (Up to 12 Months)
Participants who discontinued due to adverse events were reported in this outcome measure.
次要结局
- Percentage of Treated Migraine Attacks With Pain Freedom (PF) at 2 Hours Post-Dose(2 hours post-dose (for each treated migraine attack, up to 12-month treatment period))
- Percentage of Treated Migraine Attacks With Pain Relief (PR) at 2 Hours Post-Dose(2 hours post-dose (for each treated migraine attack, up to 12-month treatment period))
- Percentage of Treated Migraine Attacks With Freedom From Most Bothersome Symptom (MBS) at 2 Hours After Dose(2 hours post-dose (for each treated migraine attack, up to 12-month treatment period))