Randomized Controlled Trial of Lasmiditan Over Four Migraine Attacks
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,633
- 试验地点
- 136
- 主要终点
- Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack
研究概览
简要总结
The reason for this study is to see how effective and safe the study drug known as lasmiditan is in the acute treatment of 4 migraine attacks 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
- •Migraine with or without aura fulfilling the International Headache Society (IHS) diagnostic criteria 1.1 and 1.2.1
- •History of disabling migraine for at least 1 year
- •Migraine onset before the age of 50 years
- •History of 3 to 8 migraine attacks per month (<15 headache days per month) during the past 3 months
- •MIDAS score ≥11
- •Able and willing to complete an eDiary to record the details of each migraine attack treated with study drug
- •Women of child-bearing potential must be using or willing to use a highly effective form of contraception
- •Agree not to post any personal medical data or information related to the study on any website or social media site until the entire trial has completed
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 participant 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
- •Significant renal or hepatic impairment in the opinion of the investigator or if they meet hepatic monitoring criteria
- •Participants who, in the investigator's judgment, are actively suicidal and therefore deemed to be at significant risk for suicide
- •History, within past 12 months, of chronic migraine or other forms of primary or secondary chronic headache disorder (eg, hemicranias continua, medication overuse headache where headache frequency is ≥15 headache days per month)
- •Use of more than 3 doses per month of either opioids or barbiturates
- •Initiation of or a change in concomitant medication to reduce the frequency of migraine episodes within 3 months prior to screening
- •Pregnant or breast-feeding women
- •History of drug or alcohol abuse/dependence within 1 year prior to screening
- •Any medical condition or clinical laboratory test which in the judgment of the investigator makes the participant unsuitable for the study
- •Currently enrolled in any other clinical study involving an investigational product
- •Relatives of, or staff directly reporting to, the Investigator
- •Participants who are employees of the sponsor
研究组 & 干预措施
200 mg Lasmiditan MEE
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Lasmiditan (Drug)
100 milligram (mg) Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Lasmiditan (Drug)
100 milligram (mg) Lasmiditan
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Placebo (Drug)
Control 2 Sequence
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Placebo (Drug)
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Lasmiditan (Drug)
200 mg Lasmiditan
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Placebo (Drug)
Control 1 Sequence
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Lasmiditan (Drug)
Control 1 Sequence
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Placebo (Drug)
Control 2 Sequence
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attack 4.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Lasmiditan (Drug)
100 mg Lasmiditan Maximum Extended Enrollment (MEE)
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Lasmiditan (Drug)
100 mg Lasmiditan Maximum Extended Enrollment (MEE)
Participants received one 100 mg Lasmiditan tablet with one 50 mg Lasmiditan matching placebo tablet and one 100 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Placebo (Drug)
200 mg Lasmiditan MEE
Participants received two 100 mg Lasmiditan tablets with one 50 mg Lasmiditan matching placebo tablet to maintain blind. Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Placebo (Drug)
Control 1 Sequence MEE
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Lasmiditan (Drug)
Control 1 Sequence MEE
Control 1:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 4.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 3.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Placebo (Drug)
Control 2 Sequence MEE
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 4.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Lasmiditan (Drug)
Control 2 Sequence MEE
Control 2:
Participants received one 50 mg Lasmiditan matching placebo tablet and two 100 mg Lasmiditan matching placebo tablets to maintain blind for migraine attacks 1, 2, and 3.
Participants received one 50 mg Lasmiditan tablet with two 100 mg Lasmiditan matching placebo tablets to maintain blind, for migraine attack 4.
Tablets were administered orally within 4 hours of onset of a single migraine attack, up to 4 migraine attacks.
干预措施: Placebo (Drug)
Open Label Extension
Participants initially received 100 mg Lasmiditan at the first OLE visit, with flexible dosing (50, 100, or 200 mg) thereafter to optimize efficacy and tolerability.
干预措施: Lasmiditan (Drug)
结局指标
主要结局
Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack
时间窗: 2 Hours Postdose
Pain-free is defined as mild, moderate, or severe headache pain becoming none at 2 hours postdose during the first attack.
Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks
时间窗: 2 Hours Postdose
To evaluate the 2 out of 3 primary consistency endpoint, the results of ITT evaluable attacks in the lasmiditan 100-mg and 200-mg groups will be assessed, and the ITT-evaluable attacks treated with placebo in the control group will be used for comparison. For participants with more than 3 ITT evaluable attacks, only the first 3 will be considered. Pain-free was defined as mild, moderate, or severe headache pain becoming none at the indicated assessment time.
次要结局
- Percentage of Participants With 24-Hour Sustained Pain Freedom During the First Attack(24 Hours)
- Percentage of Participants With 48-Hour Sustained Pain Freedom During First Attack(48 Hours Postdose)
- Percentage of Participants With Pain Relief at 2 Hours Post Dose During the First Attack(2 Hours Postdose)
- Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 2 Out of 3 Attacks(2 Hours Postdose)
- Percentage of Participants That Are Pain Free 2 Hours Postdose During the First Attack in Triptan Insufficient Responders.(2 Hours Postdose)
- Percentage of Participants With no Disability as Measured by the Disability Item, at 2 Hours Postdose During the First Attack(2 Hours Postdose)
- Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 2 Out of 3 Attacks in Triptan Insufficient Responders(2 Hours Postdose)
- Percentage of Participants Free of Most Bothersome Symptom (MBS) Associated With Migraine at 2 Hours Postdose During the First Attack(2 Hours Postdose)
- Percentage of Participants Requiring Rescue Medication for Migraine Within 24 Hours of Treatment During the First Attack(24 Hours)
- Percentage of Participants That Are Free of Symptoms Associated With Migraine at 2 Hours Postdose During the First Attack(2 Hours Postdose)
- Percentage of Participants With Migraine Recurrence at 24 Hours During the First Attack(24 Hours)
- Percentage of Participants With Pain Freedom, Pain Relief, Freedom From MBS, and No Disability Postdose During First Attack(30 Minutes (Min) and 1 Hour (Hr) Postdose)
- Change From Baseline in Total Score as Measured by the Migraine Disability Assessment Test (MIDAS) Scale(Baseline, Week 16)
- Percentage of Participants Very Much or Much Better as Measured by Patient Global Impression of Change (PGI-C), at 2 Hours Postdose During the First Attack(2 Hours Postdose)
- Migraine Quality of Life Questionnaire (MQoLQ) Score at 24 Hours Post First Dose of Study During First Attack(24 Hours Post First Dose)
- Percentage of Participants Satisfied With Their Treatment Measured by a 4-Item Questionnaire(Week 16)
- Change From Baseline in Utility at 24 Hours Postdose as Measured by the EuroQol 5-Dimension 5-Level Scale (EQ-5D-5L) at 24 Hours Postdose During First Attack(Baseline, 24 Hours Postdose)
- Percentage of Participants That Are Pain Free at 2 Hours Postdose in at Least 3 Out of 4 Attacks(2 Hours Postdose)
- Percentage of Participants With Pain Relief at 2 Hours Postdose in at Least 3 Out of 4 Attacks(2 Hours Postdose)
- Percentage of Participants With Associated Migraines Symptoms of Nausea, Vomiting, Photophobia, and Phonophobia Present at 2 Hours Postdose for First Attack(2 Hours Postdose)