A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Chinese Participants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 787
- 试验地点
- 93
- 主要终点
- Mean change from the Observation Phase (OP) in the number of migraine days per month over the entire Double Blind Treatment (DBT) Phase
研究概览
简要总结
The purpose of this study is to learn about the effects of Rimegepant to help prevent migraine.
This study is seeking for participants who:
- Are male and female of 18 years of age or older.
- Have at least 1 year history of migraine .
- Did not take any medication for migraine before the start of this study. The study will go on for around 30 weeks, including 4 Phases and 11 Visits. Participants who are selected for the study will be randomly assigned to treatment groups. After which, the participants will enter a 12-week Double-blind Treatment (DBT) Phase. After finishing the DBT Phase, some selected participants may enter a 12-week Open-label Extension (OLE) Phase. Participants will come back to the study site at the end of Week 24 for the End of Treatment (EOT) Visit. There will be a follow-up Week 2 Visit around 14 days after the EOT visit.
Participants will be asked to take 1 tablet of study medicine every other calendar day. This need to be followed regardless of whether they have a migraine on that day or not. During the OLE Phase only, if a participant has a migraine on a non-scheduled dosing day, they may take 1 tablet of Rimegepant orally disintegrating tablet (ODT) as acute treatment for their migraine, if needed, with a maximum of 1 tablet of Rimegepant per calendar day. The study team will look at how each participant is doing with the study treatment during the regular visits at the study clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •1.Target Population: Participant has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:
- •Age of onset of migraines prior to 50 years of age
- •Migraine attacks, on average, lasting 4 to 72 hours if untreated
- •Per participant report, 4 to18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol)
- •6 or more migraine days during Observation Phase
- •Not more than 18 headache days during the Observation Phase
- •Ability to distinguish migraine attacks from tension/cluster headaches.
- •Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
排除标准
- •Participant has a history of basilar migraine or hemiplegic migraine.
- •Participants are excluded if they have had no therapeutic response with > 2 of the 9 medication categories of preventive treatment of migraine after an adequate therapeutic trial in the past 3 years per investigator's judgement.
研究组 & 干预措施
DBT Placebo/OLE Rimegepant
DBT Phase (Weeks 1 through 12): Participants will receive a single oral dose of placebo matching to rimegepant ODT EOD for 12 weeks.
OLE Phase (Weeks 13 through 24): Participants who continue to meet study entry criteria, will enter the OLE phase and receive a single oral dose of rimegepant ODT EOD for 12 weeks. If participants have a migraine on a day that they are not scheduled to dose with rimegepant, they can take one tablet of rimegepant ODT on that calendar day to treat a migraine (PRN dosing).
干预措施: Rimegepant (Drug)
DBT Placebo/OLE Rimegepant
DBT Phase (Weeks 1 through 12): Participants will receive a single oral dose of placebo matching to rimegepant ODT EOD for 12 weeks.
OLE Phase (Weeks 13 through 24): Participants who continue to meet study entry criteria, will enter the OLE phase and receive a single oral dose of rimegepant ODT EOD for 12 weeks. If participants have a migraine on a day that they are not scheduled to dose with rimegepant, they can take one tablet of rimegepant ODT on that calendar day to treat a migraine (PRN dosing).
干预措施: Placebo (Drug)
DBT Rimegepant/OLE Rimegepant
DBT Phase (Weeks 1 through 12): Participants will receive a single oral dose of rimegepant orally disintegrating tablet (ODT) EOD for 12 weeks.
OLE Phase (Weeks 13 through 24): Participants who continue to meet study entry criteria, will enter the OLE phase and receive a single oral dose of rimegepant ODT EOD for 12 weeks. If participants have a migraine on a day that they are not scheduled to dose with rimegepant, they can take one tablet of rimegepant ODT on that calendar day to treat a migraine (as needed [PRN] dosing).
干预措施: Rimegepant (Drug)
结局指标
主要结局
Mean change from the Observation Phase (OP) in the number of migraine days per month over the entire Double Blind Treatment (DBT) Phase
时间窗: OP (up to 4 weeks) and Weeks 1-12 of the DBT phase
The change from OP (up to 4 weeks) is calculated as the number of monthly migraine days during the 12 weeks of the DBT phase (Weeks 1 to 12) minus number of monthly migraine days during the OP (up to 4 weeks).
Mean Change From the Observation Phase (OP) in Number of Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)
时间窗: OP (screening of 4 weeks prior to randomization), DBT phase (Weeks 1 to 12)
A migraine day(MD) was defined as any calendar day participant experienced a qualified migraine headache (onset,continuation,or recurrence), per electronic diary(eDiary). A qualified migraine headache was defined as a migraine with/without aura,lasted for \>=30 minutes with \>=2 pain features (unilateral location,pulsating quality\[throbbing\],moderate/severe pain intensity,aggravated by or caused avoidance of routine physical activity \[e.g. walking/climbing stairs\]) and/or with \>=1 of the following associated symptoms (nausea and/or vomiting, both photophobia and phonophobia).The number(no.) of md per month (m) was prorated to 28 days and derived as:OP:28\*\[total no.of MD in OP analysis period\]/(total no.of efficacy data day in OP analysis period), monthly (4-week interval) on-DBT efficacy analysis period: 28\*(total no.of MD in m)/(total no. of efficacy data days in m),overall DBT in on-DBT efficacy analysis period:28\*(total no.of MD through m3)/(total no.of efficacy data day through m3).
次要结局
- Number of participants with AST or ALT elevations > 3x ULN concurrent with total bilirubin elevations > 2x ULN on treatment during the DBT Phase and OLE Phase.(Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase)
- Mean change from the OP in the number of migraine days per month in the first 4 weeks (Weeks 1 to 4) of the DBT Phase.(OP (up to 4 weeks) and Weeks 1-4 of the DBT phase)
- Number of participants with hepatic-related AEs on treatment during the DBT Phase and OLE Phase.(Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase)
- Proportion of participants with >= 50% reduction from the OP in the number of moderate to severe migraine days per month over the entire DBT Phase(OP (up to 4 weeks) and Weeks 1-12 of the DBT phase)
- Mean change from the OP in the number of migraine days per month in the last 4 weeks (Weeks 9 to 12) of the DBT Phase.(OP (up to 4 weeks) and Weeks 9-12 of the DBT phase)
- Mean change from baseline in the MSQoL v2.1 role function - restrictive domain score at Week 12 of the DBT Phase(OP (up to 4 weeks) and Week 12 of the DBT phase)
- Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation during the DBT Phase and OLE Phase.(Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase)
- Percentage of participants with AST or ALT elevations > 3x ULN concurrent with total bilirubin elevations > 2x ULN on treatment during the DBT Phase and OLE Phase.(Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase)
- Percentage of participants with hepatic-related AEs on treatment during the DBT Phase and OLE Phase.(Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase)
- Percentage of participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation during the DBT Phase and OLE Phase.(Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase)
- Percentage of Participants With >=50% Reduction From the OP in the Number of Moderate to Severe Migraine Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)(OP (screening of 4 weeks prior to randomization), DBT Phase (Weeks 1 to 12))
- Mean Number of Acute Migraine Medication Days Per Month Over the Entire DBT Phase (Weeks 1 to 12)(DBT phase (Weeks 1 to 12))
- Number of Participants With Any On-Treatment Adverse Events (AEs) by Severity During the DBT Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Mean Change From the OP in the Number of Migraine Days Per Month in the First 4 Weeks (Weeks 1 to 4) of the DBT Phase(OP (screening of 4 weeks prior to randomization), DBT phase (Weeks 1 to 4))
- Mean Change From the OP in the Number of Migraine Days Per Month in the Last 4 Weeks (Weeks 9 to 12) of the DBT Phase(OP (screening of 4 weeks prior to randomization), DBT phase (Weeks 9 to 12))
- Mean Change From Baseline in the Migraine-Specific Quality-of-Life Questionnaire (MSQoL) Role Function-Restrictive Domain Score at Week 12 of the DBT Phase(Baseline, DBT phase (Week 12))
- Number of Participants With Serious Adverse Events (SAEs) On-Treatment During the DBT Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With AEs Leading to Study Intervention Discontinuation During the DBT Phase(DBT phase: maximum of 12 weeks)
- Number of Participants With Any On-Treatment Grade 3 to 4 Laboratory Test Abnormalities During the DBT Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With Any On-Treatment AEs by Severity During the OLE Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With SAEs On-Treatment During the OLE Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With AEs Leading to Study Intervention Discontinuation on Treatment During the OLE Phase(OLE phase: maximum of 12 weeks)
- Number of Participants With Any On-Treatment Grade 3 to 4 Laboratory Test Abnormalities During the OLE Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With ALT or AST Elevations >3* Upper Limit of Normal (ULN) Concurrent With Total Bilirubin (TBL) Elevations >2*ULN On-Treatment During the DBT Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With ALT or AST Elevations >3*ULN Concurrent With TBL Elevations >2*ULN On-Treatment During the OLE Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With Hepatic-related AEs On-Treatment During the DBT Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With Hepatic-related AEs Leading to Study Intervention Discontinuation On-Treatment During the DBT Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With Hepatic-related AEs On-Treatment During the OLE Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))
- Number of Participants With Hepatic-Related AEs Leading to Study Intervention Discontinuation On-Treatment During the OLE Phase(From Day 1 up to 4 weeks post last dose (maximum up to 16 weeks))