Clinical trial NCT05810038: A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Chinese Participants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Migraine
Keywords: Rimegepent
preventive treatment
migraine.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-04-12
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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:

1. Age of onset of migraines prior to 50 years of age
2. Migraine attacks, on average, lasting 4 to 72 hours if untreated
3. 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)
4. 6 or more migraine days during Observation Phase
5. Not more than 18 headache days during the Observation Phase
6. Ability to distinguish migraine attacks from tension/cluster headaches.
7. Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.

Exclusion Criteria:

1. Participant has a history of basilar migraine or hemiplegic migraine.
2. 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.

Primary outcomes:
measure: Mean change from the Observation Phase (OP) in the number of migraine days per month over the entire Double Blind Treatment (DBT) Phase
timeFrame: OP (up to 4 weeks) and Weeks 1-12 of the DBT phase
Secondary outcomes:
measure: 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
timeFrame: OP (up to 4 weeks) and Weeks 1-12 of the DBT phase
measure: 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.
timeFrame: OP (up to 4 weeks) and Weeks 1-4 of the DBT phase
measure: 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.
timeFrame: OP (up to 4 weeks) and Weeks 9-12 of the DBT phase
measure: Mean change from baseline in the MSQoL v2.1 role function - restrictive domain score at Week 12 of the DBT Phase
timeFrame: OP (up to 4 weeks) and Week 12 of the DBT phase
measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation during the DBT Phase and OLE Phase.
timeFrame: Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
measure: Percentage of participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation during the DBT Phase and OLE Phase.
timeFrame: Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
measure: 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.
timeFrame: Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
measure: 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.
timeFrame: Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
measure: Number of participants with hepatic-related AEs on treatment during the DBT Phase and OLE Phase.
timeFrame: Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
measure: Percentage of participants with hepatic-related AEs on treatment during the DBT Phase and OLE Phase.
timeFrame: Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second People's hospital of Hefei
state: Anhui
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Chongqing
country: China
facility: The fourth people's hospital of chongqing
state: Chongqing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The 900th Hospital of Joint Logistics Support Force, PLA
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou university second hospital
state: Gansu
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Zhengzhou
country: China
facility: People's Hospital of Zhengzhou
state: Henan
city: Wuhan City
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Lianyungang
country: China
facility: The Second People's Hospital of Lianyungang
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Suzhou University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi No. 2 People's Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Subei People's Hospital of Jiangsu province
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Pingxiang
country: China
facility: Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical Hospital
state: NING XIA Province
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University
state: Shaanxi
city: Dongying
country: China
facility: Shengli Oilfield Central Hospital
state: Shandong
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Jining City
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Liaocheng
country: China
facility: Liaocheng people's Hospital
state: Shandong
city: Linyi City
country: China
facility: Linyi People's Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Central Hospital
state: Shandong
city: Rizhao City
country: China
facility: People's Hospital of Rizhao
state: Shandong
city: Shanghai
country: China
facility: Huashan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Kunming
country: China
facility: The Second Affiliated hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hosptial of Wenzhou Medical University
state: Zhejiang
city: Beijing
country: China
facility: Peking University People's Hospital
city: Changzhi City
country: China
facility: Heping Hospital Affiliated to Changzhi Medical College
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
city: Tianjin
country: China
facility: Tianjin Union Medical Center
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: