RandoMized, DOuble-bliNd, PlacebO-coNtrolled Trial Of Lasmiditan in a Single Migraine Attack in Japanese Patients SuFfering From Migraine With or WithoUt Aura - the MONONOFU Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 846
- 试验地点
- 34
- 主要终点
- Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)
研究概览
简要总结
This study will assess the efficacy and safety of lasmiditan in the acute treatment of a migraine attack in Japanese adult participants with or without aura.
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
- Double (Participant, Investigator)
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
- •Participants with migraine with or without aura fulfilling the International Classification of Headache Disorders (ICHD)-
- •History of disabling migraine for at least 1 year.
- •Migraine Disability Assessment Test (MIDAS) score ≥
- •Migraine onset before the age of 50 years.
- •History of 3-8 migraine attacks per month and <15 headache days per month during the past 3 months.
排除标准
- •Known hypersensitivity to lasmiditan, or to any excipient of lasmiditan oral tablets.
- •History or evidence of hemorrhagic stroke, epilepsy, or any other condition placing the patient at increased risk of seizures.
- •History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo, Meniere's disease, vestibular migraine, and other vestibular disorders.
- •History of diabetes mellitus with complications (diabetic retinopathy, nephropathy, or neuropathy).
- •History of orthostatic hypotension with syncope.
研究组 & 干预措施
50 milligram (mg) Lasmiditan
50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
干预措施: Lasmiditan (Drug)
50 milligram (mg) Lasmiditan
50 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
干预措施: Placebo (Drug)
100 mg Lasmiditan
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
干预措施: Lasmiditan (Drug)
100 mg Lasmiditan
100 mg Lasmiditan tablet plus two placebo tablets (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
干预措施: Placebo (Drug)
200 mg Lasmiditan
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
干预措施: Lasmiditan (Drug)
200 mg Lasmiditan
200 mg Lasmiditan (two 100 mg tablets) plus one placebo tablet (to match Lasmiditan dose) administered once orally to treat a single migraine attack.
干预措施: Placebo (Drug)
Placebo
Placebo tablets (to match 50 mg, 100 mg, 200 mg Lasmiditan dose tablets) administered once orally to treat a single migraine attack.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Are Headache Pain Free In High Dose Group (200 mg Lasmiditan)
时间窗: 2 Hours Postdose
Percentage of participants who were headache pain free (defined as moderate or severe pain becoming none) at 2 hours postdose.
次要结局
- Percentage of Participants With Headache Pain Relief(1 Hour Postdose)
- Percentage of Participants Who Are Headache Pain Free in Each Dose Group(2 Hours Postdose)
- Percentage of Participants Who Are Free of Most Bothersome Symptoms (MBS) Associated With Migraine(2 Hours Postdose)
- Percentage of Participants With 24-Hour Sustained Pain Freedom(24 Hours Postdose)
- Percentage of Participants With 48-Hour Sustained Pain Freedom(48 Hours Postdose)
- Percentage of Participants That Are Free of Phonophobia(2 Hours Postdose)
- Percentage of Participants That Are Free of Photophobia(2 Hours Postdose)
- Percentage of Participants That Are Free of Nausea(2 Hours Postdose)
- Percentage of Participants That Are Free of Vomiting(2 Hours Postdose)
- Percentage of Participants With Pain Freedom(1 Hour Postdose)
- Percentage of Participants With Freedom From Most Bothersome Symptom (MBS)(1 Hour Postdose)
- Percentage of Participants With No Disability(2 Hours Postdose)
- Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Health Status Index Score Japan(Baseline, 24 Hours Postdose)
- Change From Baseline on the EuroQol 5 Dimension 5-level Scale (EQ-5D-5L) Visual Analog Scale(Baseline, 24 Hours Postdose)
- Percentage of Participants With Very Much or Much Better as Measured by the Patient Global Impression of Change (PGI-C)(2 Hours Postdose)
- Health-Related Quality of Life (HRQoL) Total Score as Measured by the 24-Hour Migraine Quality of Life Questionnaire (MQoLQ)(24 Hours Postdose)