CONFIDENCE: A PROSPECTIVE OBSERVATIONAL STUDY WITH ACUTE TREATMENT OF RIMEGEPANT ODT ON CONSISTENCY, SATISFACTION AND TOLERABILITY OF TREATMENT IN THE REAL WORLD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 467
- 试验地点
- 1
- 主要终点
- Satisfaction with prescribed medication
研究概览
简要总结
This study aims at characterizing the effectiveness of rimegepant as an acute migraine treatment in a real world setting on two aspects:
- Consistency of response to rimegepant across multiple attacks
- Effectiveness of rimegepant in users taking concomitant migraine preventive medications, namely monoclonal antibodies targeting CGRP and onabotulinumtoxinA
详细描述
This study will be conducted in a real-world setting in the US using a bespoke interface contained in the Migraine Buddy mobile application. Participants who report using rimegepant for the acute treatment of migraine will be recruited and will be asked to complete a series of questionnaires during the screening and study period. Patient reported outcome measures will be collected at study enrollment, daily during the 28-day observation period, and at the end of the study period.
Research Questions:
- In adult patients currently receiving a prescription for rimegepant for the acute treatment of migraine, what is the population-level consistency of rimegepant response for pain reduction, meaningful pain relief, performance in daily activities, and return to normal function across multiple attacks in a real-world setting, regardless of prophylactic background?
- What is the satisfaction level of patients receiving rimegepant on background migraine prophylaxis (specifically, anti-CGRP mAbs or onabotulinumtoxinA (Botox)?
- What is the efficacy, safety, and tolerability of rimegepant for the acute treatment of migraine, when taken in combination with preventive medications that act on the same pathway?
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Female or male patients with migraine ≥18 years old
- •Having received a prescription for rimegepant for acute treatment
- •Experienced between 3 and 14 Headache days in the last 30 days
- •Planning to use rimegepant for attacks happening during the next 30 days
排除标准
- •Report currently using rimegepant as preventive
- •Report currently using concomitantly onabotulinumtoxin and any of the mAbs
- •Currently participating in a Migraine-related clinical trial
- •Reports a diagnosis from a doctor or other health professional of cluster headache, post-traumatic headache, new daily persistent headache, or hemicrania continua
结局指标
主要结局
Satisfaction with prescribed medication
时间窗: Day 30
Satisfaction with prescribed medication (rimegepant-treated attacks) as measured by 5 questions with a 7-point rating scale; Distribution analysis and Responder Yes/No. Responder definition: Extremely Satisfied, Satisfied, Slightly Satisfied."
Population level consistency
时间窗: Day 30
Population level consistency will be determined utilizing the daily diary item 'meaningful pain relief' when rimegepant is used to acutely treat a migraine attack. Those who report meaningful pain relief at \<1 or 1-2 hours after taking rimegepant will be considered a 'responder'. Those who report meaningful pain relief \>2 hours or those who did not achieve meaningful relief/used another acute treatment since taking rimegepant will be considered 'delayed responder' or 'non-responder,' respectively. Population level consistency will be evaluated as the proportion of responders for each attack treated with rimegepant.
Assessments of meaningful clinical effect
时间窗: Day 30
Assessments of meaningful clinical effect will be measured by the rates in achieving meaningful pain relief at other timepoints, rates of improvement of migraine severity and functional disability, satisfaction with treatment and rates of acute treatment optimization. Responder definition: Improvement in functional disability 2 hours after taking rimegepant vs at time of intake (reduction by at least 1 category:e.g., from severely impaired to moderately impaired, from moderately impaired to mildly impaired, from mildly impaired to no disability).
meaningful improvement in functioning
时间窗: Day 30
Experience of "meaningful improvement in functioning" between 1 and 4 hours after intake.
次要结局
- Effectiveness of rimegepant in users taking concomitant migraine preventive medications(Day 30)