An Open-label, LonG-term, Safety Study of LAsmiDItan (100 mg and 200 mg) in the Acute Treatment Of MigRaine (GLADIATOR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,171
- 试验地点
- 159
- 主要终点
- Number of Participants With at Least 1 Treatment Emergent Adverse Event
研究概览
简要总结
This is a prospective, randomized, open-label study in subjects with migraine who have completed the Phase 3 studies, COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174) or for a subset of lasmiditan-naïve subjects with migraine. The study is designed to evaluate the safety and tolerability of long-term intermittent use of lasmiditan 100 mg and of lasmiditan 200 mg, as the first dose and as a second dose, for the acute treatment of migraine. Long term efficacy will also be evaluated.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to give written informed consent and authorize Health Insurance Portability and Accountability Act (HIPAA).
- •Completed COL MIG-301 or COL MIG-302 within the last 12 weeks. Subjects that completed COL MIG-301 prior to COL MIG-305 being available will be allowed to enroll as long as enrollment occurs within 4 weeks of COL MIG-305 activation at their site. (NOTE: Additional subjects may qualify if they completed COL MIG-301 or COL MIG-302 >12 weeks prior or if they have not participated in either prior study, but meet eligibility criteria outlined for COL MIG-302.)
- •Females of child-bearing potential must be using or willing to use a highly effective form of contraception (e.g. combined oral contraceptive, intrauterine device (IUD), abstinence or vasectomized partner).
- •Able and willing to complete an electronic diary to record details of all migraine attacks treated with study drug.
排除标准
- •Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the subject unsuitable for the study.
- •Pregnant or breast-feeding women.
- •Women of child-bearing potential not using or not willing to use highly effective contraception.
- •Participant is at imminent risk of suicide (positive response to question 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- •Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes since completing COL MIG-301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
- •Participation in any clinical trial of an experimental drug or device since completing EoS/Visit 2 of COL MIG 301/LAHJ (NCT02439320) or COL MIG-302/LAHK (NCT02605174).
研究组 & 干预措施
Lasmiditan 100mg
Participants received oral dose of 100 milligrams (mg) Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond within 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
干预措施: Lasmiditan (Drug)
Lasmiditan 200mg
Participants received oral dose of 200mg Lasmiditan with in four hours of onset of migraine attack. If the migraine did not respond with in 2 hours after first dose or if responded and recurred then a second dose was permitted within 24 hours after first dose.
干预措施: Lasmiditan (Drug)
结局指标
主要结局
Number of Participants With at Least 1 Treatment Emergent Adverse Event
时间窗: 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.
次要结局
- Percentage of Migraine Attacks With Most Bothersome Symptom-Free (MBS) at 2 Hours After Dose(Up to 12 months)
- Percentage of Migraine Attacks With Pain Freedom (PF) at 2 Hours After Dose(Up to 12 months)