RimegepAnt effectIvenesS and tolErability as Migraine Preventive Treatment: a Prospective, Multicentric, Cohort Study (RAISE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Changes in migraine frequency after three months of treatment
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 preventive 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 gepant, 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 migraine. A previous randomized, placebo-controlled phase 2/3 trial demonstrated its effectiveness and tolerability in the preventive setting for patients with episodic and chronic migraine. Previous studies also demonstrated a good tolerability profile. The most commonly reported adverse events were nausea, nasopharyngitis, upper respiratory tract infections and urinary tract infections.
In this prospective multicentric study the investigators aim to evaluate rimegepant effectiveness and tolerability as preventive 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 visit. The observation period will last for two years during which patients will take rimegepant 75 mg orally disintegrating tablet every other day for a time period related to eventual approval of reimbursability criteria.
Data will be collected at baseline and every three months for two years. Subjects will be asked to keep a headache diary to collect monthly headache and migraine days, migraine severity, associated symptoms and drug consumption. Questionnaires will be collected every three months.
Data collection will focus on: i) demographic data, ii) migraine history, iii) pain intensity, iv) presence and evolution of migraine associated symptoms and aura, v) migraine associated disability, vi) tolerability and eventual treatment- emergent adverse events, vii) treatment persistence, viii) questionnaires related to disability, allodynia, quality of life, interictal burden and effectiveness of the ongoing acute and preventive treatments. The online database REDCap will be used for data collection.
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 or migraine with aura, according to the 3rd edition of the International Classification of Headache Disorder (ICHD-III);
- •At least 4 monthly migraine days;
- •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;
- •Diagnosis of chronic migraine
- •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.
- •Changes in preventive treatments in the month before the first administration of rimegepant
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 (Drug)
结局指标
主要结局
Changes in migraine frequency after three months of treatment
时间窗: Baseline (T0) - 3 months of treatment with rimegepant (T3)
Changes in monthly migraine days after three months of treatment with rimegepant compared to baseline (continuous variable)
Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) after three months of treatment with rimegepant
时间窗: Baseline (T0) - 3 months of treatment with rimegepant (T3)
Percentage of 50% Responders (namely patients who presented a reduction of MMDs \>/ = 50% compared to baseline) after three months of treatment with rimegepant
次要结局
- Changes in migraine frequency across twelve months of rimegepant treatment(Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Percentage of 50% Responders (namely patients who presented a reduction of MMDs >/ = 50% compared to baseline) across twelve months of treatment with rimegepant(Baseline (T0) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Changes in migraine disability (HIT-6)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Evaluation of any adverse event (quantitative)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Changes in migraine disability (MIDAS)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Evaluation of any adverse event (qualitative)(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Changes in allodynia across rimegepant treatment (ASC-12)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Changes in interictal burden across rimegepant treatment (MIBS-4)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Percentage of patients with Medication overuse headache reverted during treatment(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Evaluation of serious adverse event(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Evaluation of adverse event leading to treatment discontinuation(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Consistency of treatment response(3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Changes in response to acute migraine treatment (m-TOQ)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Changes in quality of life across rimegepant treatment (MSQ)(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
- Percentage of patients with Medication overuse reverted during treatment(Baseline (T0) - 3 months (T3) - 6 months (T6) - 12 months (T12) of treatment with rimegepant)
研究者
Luigi Francesco Iannone
Researcher
University of Modena and Reggio Emilia