NCT04218162已完成3 期
A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Evaluate Efficacy and Safety of Lasmiditan Compared to Placebo in the Acute Treatment of Migraine
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Percentage of Participants Headache Pain Free at 2 Hours Post Dose
研究概览
简要总结
A randomized, double-blind, placebo-controlled parallel group study to evaluate efficacy and safety of lasmiditan tablet compared to Placebo in the acute treatment of Migraine
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
- •Able and willing to give written informed consent.
- •Male or female, aged 18 years or above.
- •Participants with migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1 (International Headache Classification (ICHD-3).
- •History of disabling migraine for at least 1 year.
- •Migraine Disability Association (MIDAS) score ≥
- •Migraine onset before the age of 50 years.
- •History of 3 - 8 migraine attacks per month (< 15 headache days per month).
- •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 the migraine attack treated with study drug.
排除标准
- •Any medical condition or clinical laboratory test which in the judgment of the Investigator makes the participant unsuitable for the study.
- •Pregnant or breast-feeding women.
- •Known hypersensitivity to lasmiditan or to any excipient of lasmiditan oral tablets, or any sensitivity to lasmiditan.
- •History or evidence of hemorrhagic stroke, epilepsy or any other condition placing the participant at increased risk of seizures.
- •History of recurrent dizziness and/or vertigo including benign paroxysmal positional vertigo (BPPV), Meniere's disease, vestibular migraine, and other vestibular disorders.
- •History of diabetes mellitus with complications (diabetic retinopathy, nephropathy or neuropathy).
- •History within the previous three years or current evidence of abuse of any drug, prescription or illicit, or alcohol.
- •History of orthostatic hypotension with syncope.
- •Significant renal or hepatic impairment.
- •Participant is at imminent risk of suicide (positive response to question 4 or 5) on the Columbia-Suicide Severity Rating Scale (C-SSRS) or had a suicide attempt within six months prior to screening.
- •Participation in any clinical trial of an experimental drug or device in the previous 30 days.
- •Known Hepatitis B or C or human immunodeficiency virus(HIV) infection. History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (e.g. hemicranias continua, medication overuse headache) where headache frequency is ≥15 headache days per month.
- •Use of more than 3 doses per month of either opiates or barbiturates.
- •Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within three (3) months prior to Screening/Visit 1.
研究组 & 干预措施
Lasmiditan 50mg
Experimental
干预措施: Lasmiditan 50mg (Drug)
Lasmiditan 100mg
Experimental
干预措施: Lasmiditan 100mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Headache Pain Free at 2 Hours Post Dose
时间窗: 2 hours post dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
次要结局
- Number of Participants With Treatment Emergent Adverse Events(From Baseline Up to End of Study)
- Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free(2 hours post dose)
- Percentage of Participants With Headache Relief(2 hours post dose)
- Number of Participants With Headache Recurrence(2 Hours Post Dose Up to 48 Hours)
- Percentage of Participants Use of Rescue Medication(From 2 Hours Post Dose Up to 24 Hours)
研究者
研究点 (1)
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