A Study of Two Doses of LAsMiditan (100 mg and 200 mg) Compared to Placebo in the AcUte Treatment of MigRAIne: A Randomized, Double-blind, Placebo-controlled Parallel Group Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,231
- 试验地点
- 75
- 主要终点
- Percentage of Participants Who Are Headache Pain Free
研究概览
简要总结
This is a prospective randomized, double-blind, placebo-controlled study in participants with disabling migraine (Migraine Disability Assessment (MIDAS) score ≥ 11).
详细描述
Participants will be asked to treat a migraine attack with study drug on an outpatient basis. Participants will be provided with a dosing card containing a dose for initial treatment and a second dose to be used for rescue or recurrence of migraine. Each participant's study participation will consist of a screening visit (Visit 1) with a telephone contact within 7 days to confirm eligibility, a Treatment Period of up to 8 weeks, and an End-of-Study (EoS) visit (Visit 2) within one week (7 days) of treating a single migraine attack. The total time on study is approximately 11 weeks.
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 —（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.
- •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) 2004).
- •History of disabling migraine for at least 1 year.
- •MIDAS score ≥
- •Migraine onset before the age of 50 years.
- •History of 3 - 8 migraine attacks per month (< 15 headache days per month).
- •Male or female, aged 18 years or above.
- •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.
排除标准
- •Pregnant or breast-feeding women.
- •Women of child-bearing potential not using or not willing to use highly effective contraception.
- •Known coronary artery disease, clinically significant arrhythmia or uncontrolled hypertension.
- •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 C-SSRS) or had a suicide attempt within six months prior to the screening visit.
- •Known Hepatitis B or C or 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 greater than 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 100 mg
Oral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
干预措施: Lasmiditan 100 mg (Drug)
Lasmiditan 100 mg
Oral tablet. Lasmiditan 100 mg plus placebo (to match 200 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
干预措施: Placebo (matches lasmiditan doses) (Drug)
Lasmiditan 200 mg
Oral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
干预措施: Lasmiditan 200 mg (Drug)
Lasmiditan 200 mg
Oral tablet. Lasmiditan 200 mg plus placebo (to match 100 mg tablet). One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
干预措施: Placebo (matches lasmiditan doses) (Drug)
Placebo
Oral tablet. Placebo tablets match lasmiditan 100 mg and lasmiditan 200 mg. One dose for acute treatment of migraine. Second dose for rescue or recurrence of migraine allowed within 24 hours.
干预措施: Placebo (matches lasmiditan doses) (Drug)
结局指标
主要结局
Percentage of Participants Who Are Headache Pain Free
时间窗: 2 hours post dose
The percentage of participants defined as mild, moderate, or severe headache pain becoming none.
Percentage of Participants Who Are Most Bothersome Symptom (MBS) Free
时间窗: 2 hours post dose
The percentage of participants defined as the associated symptom present and identified as MBS (nausea, photophobia, or phonophobia) prior to dosing being absent.
次要结局
- Percentage of Participants Photophobia Free(2 hours post dose)
- Percentage of Participants Nausea Free(2 hours post dose)
- Participants With Serious Adverse Events (SAE)(Baseline up to 11 weeks)
- Percentage of Participants Who Have Headache Relief After First Dose(2 hours post dose)
- Percentage of Participants Who Used Rescue Medication(Anytime 24-48 hours post dose)
- Percentage of Participants Phonophobia Free(2 hours post dose)
- Percentage of Participants With Headache Recurrence(From 2 hours post dose up to 48 hours)