Effectiveness and Tolerability of Rimegepant as Acute Migraine Treatment: a Prospective, Multicentric, Cohort Study (GAINER)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Headache pain freedom at 2 hours post-dose during the first attack
研究概览
简要总结
The purpose of this prospective and multicentric study is to evaluate the effectiveness and tolerability of rimegepant as acute migraine treatment in a cohort of episodic or chronic migraine patients.
详细描述
Rimegepant belongs to the gepants family, small molecules calcitonin gene-related peptide (CGRP) receptor antagonists. It is a new generation gepants, currently available as an orally disintegrating tablet at a single dose of 75 mg. It has a double indication both for acute treatment for migraine with and without aura and preventive treatment of episodic migraine. Previous randomized, placebo-controlled phase 3 trials and open label extensions demonstrated its effectiveness in the acute setting for a single migraine attack of both the oral tablet and the orally disintegrating tablet. Pooled analysis of previous randomized clinical trials also showed rimegepant effectiveness in patients with a history of insufficient response to triptans.
Previous studies also demonstrated a good tolerability profile. The most commonly reported adverse events were nausea, nasopharyngitis, upper respiratory tract infections and urinary tract infection.
In this prospective multicentric study we aim to evaluate Rimegepant 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 Rimegepant 75 mg orally disintegrating tablet.
Data will be collected at baseline, during at least 4 migraine attacks treated with Rimegepant and at 3 months follow-up.
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 gepants;
- •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 migraine(< 15 monthly headache days) with or without aura according to ICHD-III criteria.
干预措施: Rimegepant 75 MG Disintegrating Oral Tablet (Drug)
Chronic migraine
Patients affected by chronic migraine according to ICHD-III criteria.
干预措施: Rimegepant 75 MG Disintegrating Oral Tablet (Drug)
结局指标
主要结局
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).
Occurrence of treatment-emergent adverse events
时间窗: 12 weeks
To evaluate the safety and tolerability of Rimegepant in migraine subjects.
次要结局
- Headache pain freedom at 2 hours post-dose across all treated attacks(2 hours post-dose for all treated attacks)
- 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)
- 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)
- Freedom from the most bothersome symptom (MBS) associated with migraine at 2 hours post-dose during the first attack(2 hours post-dose)
- Headache recurrence for the first-attack(between 2 hours and 24 hours post-dose)
- Rescue medications use for the first attack(between 2 hours and 24 hours post dose)
- Treatment satisfaction(2 hours post-dose for all treated attacks)
- Self-reported treatment effectiveness(12 weeks)
研究者
Luigi Francesco Iannone
Researcher
University of Florence