AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, RANDOMIZED, 2-ARM STUDY TO INVESTIGATE THE PREVENTION OF CHRONIC MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN PARTICIPANTS 18 YEARS OF AGE OR OLDER
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 400
- 试验地点
- 21
- 主要终点
- Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase
研究概览
简要总结
Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day. This study evaluates once daily rimegepant for the preventive treatment of chronic migraine.
After a 28-day observation period without study intervention, eligible participants will be randomized in a 1:1 ratio to receive either rimegepant 75 mg orally disintegrating tablet (ODT) or matching placebo once daily for 12 weeks under double-blind conditions. Participants who remain eligible at the end of the double-blind treatment phase will enter a 12-week open-label treatment period, during which all participants will receive open-label rimegepant 75 mg once daily. During this period, participants may also take an additional rimegepant tablet for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. A 28-day follow-up period completes the approximately 32-week study.
The primary objective of the study is to determine whether once-daily rimegepant is more effective than placebo in reducing monthly migraine days relative to the observation period in adults with chronic migraine. Secondary objectives include evaluating differences between rimegepant and placebo in migraine responder rates, headache severity, acute migraine medication use, quality of life, work productivity, cognitive functioning, and safety and tolerability.
Approximately 400 adults aged 18 years or older with a diagnosis of chronic migraine for at least 1 year will be enrolled at multiple study sites.
详细描述
This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of rimegepant 75 mg administered once daily for the preventive treatment of chronic migraine in adults. Approximately 400 participants with chronic migraine will complete a 28-day Observation Phase and then be randomized in a 1:1 ratio to receive either rimegepant 75 mg or placebo during a 12-week Double-Blind Treatment (DBT) Phase.
The primary objective is to determine whether once-daily rimegepant is superior to placebo in reducing monthly migraine days in adults with chronic migraine. Secondary objectives include evaluation of migraine responder rates, headache frequency and severity, acute migraine medication use, quality of life, headache-related disability, work productivity, cognitive functioning, and patient-reported improvement.
Participants will record migraine and headache information using an electronic diary and will complete protocol-specified efficacy and safety assessments throughout the study. Safety evaluations will include monitoring of adverse events, clinical laboratory assessments, vital signs, electrocardiograms, and other protocol-defined safety measures.
Eligible participants who complete the DBT Phase and remain eligible may enter a 12-week Open-Label Extension (OLE) Phase, during which all participants will receive open-label rimegepant 75 mg once daily. During the OLE Phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. Following completion or discontinuation of study treatment, participants will enter a 28-day Follow-Up Phase.
The study is designed to determine whether once-daily rimegepant provides superior efficacy to placebo for the preventive treatment of chronic migraine in adults and to further characterize the safety and tolerability profile of daily rimegepant administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, study site personnel, sponsor personnel, and outcome assessors will remain blinded to treatment assignment during the double-blind treatment phase. Participants will receive either rimegepant 75 mg once daily or matching placebo. Following completion of the double-blind phase, eligible participants may enter an open-label extension phase in which all participants will receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month.
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
- •Male or female participants ≥18 years of age.
- •Diagnosis of chronic migraine, with or without aura, according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.
- •History of migraine for at least 1 year before screening.
- •Migraine onset before 50 years of age and chronic migraine onset before 65 years of age.
- •Migraine attacks lasting 4 to 72 hours when untreated or unsuccessfully treated.
- •During the 3 months prior to screening, an average of:
- •≥15 monthly headache days (MHDs),
- •including ≥8 monthly migraine days (MMDs),
- •and ≥1 non-headache day per month.
- •Completion of the Observation Phase and fulfillment of all protocol-defined eligibility requirements prior to randomization.
- •Willing and able to comply with study procedures, including completion of the electronic diary.
排除标准
- •Prior use of rimegepant for migraine prevention.
- •History of treatment failure of:
- •2 gepants, or
- •2 CGRP-targeting biologics, or
- •1 gepant and ≥1 CGRP-targeting biologic.
- •Failure of >4 migraine preventive medications, including at least 2 with different mechanisms of action.
- •Any medical or psychiatric condition, or clinically significant laboratory abnormality, that in the investigator's judgment may increase risk to the participant or interfere with study participation or interpretation of results. This includes, but is not limited to, uncontrolled hypertension or a history of Raynaud's phenomenon.
- •Pregnant, breastfeeding, planning to become pregnant, or planning to initiate breastfeeding during the study.
- •Positive amphetamine screening result unless attributable to prescribed stimulant therapy that has been stable for at least 3 months prior to Visit 1 and is expected to remain stable throughout study participation.
- •Use of investigational products or participation in another clinical study within protocol-defined exclusion windows.
- •Any other condition that, in the opinion of the investigator or sponsor, would make study participation unsafe or compromise study conduct.
研究组 & 干预措施
Rimegepant 75 mg orally disintegrating tablet (ODT) once daily
Participants will receive rimegepant 75 mg orally disintegrating tablet (ODT) once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month.
干预措施: Rimegepant (Drug)
Matching placebo once daily for 12 weeks during the double-blind treatment phase
Participants will receive matching placebo once daily during the 12-week double-blind treatment phase. Eligible participants may subsequently enter a 12-week open-label extension phase and receive open-label rimegepant 75 mg once daily. During the open-label extension phase, participants may also take an additional dose of rimegepant 75 mg for the acute treatment of breakthrough migraine attacks, up to 10 doses per month.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase
时间窗: 12 Weeks
Change from the Observation Phase in the number of monthly migraine days (MMDs) over the 12-week Double-Blind Treatment Phase. Monthly migraine days will be assessed using participant-reported electronic diary data.
次要结局
- Percentage of Participants Achieving a ≥50% Reduction From the Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase(12 Weeks)
- Change From Observation Phase in Moderate or Severe Monthly Headache Days Over the Entire Double-Blind Treatment Phase(12 Weeks)
- Change From Observation Phase in Monthly Acute Migraine Medication Use Days Over the Entire Double-Blind Treatment Phase(12 Weeks)
- Change From Baseline in Migraine-Specific Quality of Life Questionnaire (MSQ) Restrictive Role Function Domain Score(Week 12)
- Change From Observation Phase in Monthly Migraine Days Over the Entire Double-Blind Treatment Phase in Participants With Historical Medication Overuse Headache and Medication Overuse(12 Weeks)
- Change From Baseline in MSQ Restrictive Role Function Domain Score in Participants With Historical Medication Overuse Headache and Medication Overuse(Week 12)
- Percentage of Participants Achieving Medication Overuse Headache Remission(12 Weeks)