Effectiveness and Tolerability of Lasmiditan as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Occurrence of treatment-emergent adverse events
研究概览
简要总结
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of lasmiditan as acute migraine treatment in a cohort of episodic or chronic migraine patients.
详细描述
Lasmiditan is a serotonin 5-HT1F receptor agonist. It is available in three different dosages (namely 50, 100 and 200 mg) with oral administration. Phase 3 double-blind randomized controlled studies demonstrated its effectiveness 2h post-dose in a single migraine attack and consistent effectiveness across four different attacks.
The lack of vasoconstrictive activity allow its use also in patients with cardiovascular medical history. This finding was also confirmed in a real-world study. As it is a small molecule with access to the central nervous system predominant adverse events are CNS-related (as dizziness, somnolence and paraesthesia).
In this prospective multicentric study the Investigators aim to evaluate lasmiditan effectiveness and tolerability as acute migraine treatment in a real-world setting. Subjects who meet the inclusion criteria will be enrolled and will participate in the study. Baseline demographic and clinical data will be collected at the baseline. Patients will be asked to treat their next migraine attack with lasmiditan 50 - 100 - 200 mg oral tablet.
Data will be collected at baseline, during at least 4 migraine attacks treated with lasmiditan and at 3 months follow-up.
Subjects will be asked to complete assessment of their migraine attack at baseline and at 30 - 60 - 90 and 120 minutes after administration of the acute treatment for at least four migraine attacks. A final timepoint at 24 hours post-dose will be assessed only for the first attack.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Diagnosis of migraine without aura, migraine with aura, or chronic migraine according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III).
- •At least 3 MMDs
- •Good compliance to study procedures
- •Availability of headache diary at least of the preceding months before enrollment
排除标准
- •Subjects with contraindications for use of ditans;
- •Concomitant diagnosis of medical diseases and/or comorbidities that, in the Investigator's opinion might interfere with study assessments;
- •medical comorbidities that could interfere with study results;
- •Pregnancy and breastfeeding.
研究组 & 干预措施
Episodic migraine
Patients affected by an episodic pattern (< 15 monthly headache days) migraine with or without aura according to ICHD-III criteria.
干预措施: Lasmiditan (Drug)
Chronic migraine
Patients affected by chronic migraine according to ICHD-III criteria.
干预措施: Lasmiditan (Drug)
结局指标
主要结局
Occurrence of treatment-emergent adverse events
时间窗: 12 weeks
To evaluate the safety and tolerability of Lasmiditan in migraine subjects
Headache pain freedom at 2 hours post dose during the first attack
时间窗: 2 hours post-dose
The percentage of subjects that report no headache pain at 2 hours after drug intake. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe).
次要结局
- Freedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack(2 hours post-dose)
- Headache pain relief at 2 hours post-dose during the first attack(2 hours post-dose)
- Headache pain relief at 2 hours post-dose across all treated attacks(2 hours post-dose for all treated attacks)
- Headache recurrence for the first-attack(between 2 hours and 24 hours post-dose)
- Headache pain freedom at 2 hours post dose across all treated attacks(2 hours post-dose for all treated attacks)
- Rescue medications use for the first attack(between 2 hours and 24 hours post dose)
- Self-reported treatment effectiveness(12 weeks)
- Ability to function normally at 2 hours post-dose during the first attack(2 hours post-dose)
- Ability to function normally at 2 hours post-dose across all treated attacks(2 hours post-dose for all treated attacks)
- Treatment satisfaction(2 hours post-dose for all treated attacks)
研究者
Luigi Francesco Iannone
Researcher
University of Modena and Reggio Emilia