A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.

Migraine Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05810038
• Other study ID #: C4951019
• Secondary ID: BHV3000-319
• Status: Recruiting
• Phase: Phase 3
• Start date: May 15, 2023
• Est. completion date: December 13, 2025

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 784
• Est. completion date: December 13, 2025
• Est. primary completion date: September 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Rimegepant
Rimegepant
• Placebo
matching placebo

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Baotou Medical College	Baotou	Inner Mongolia
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing
China	The first hospital of Jilin University	Changchun	Jilin
China	The First hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Heping Hospital Affiliated to Changzhi Medical College	Changzhi
China	Heping Hospital Affiliated to Changzhi Medical College	Changzhi City
China	Chongqing University Three Gorges Hospital	Chongqing
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The fourth people's hospital of chongqing	Chongqing	Chongqing
China	Shengli Oilfield Central Hospital	Dongying	Shandong
China	Shengli Oilfield Central Hospital	Dongying	Shandong
China	The 900th Hospital of Joint Logistics Support Force, PLA	Fuzhou	Fujian
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	The Second People's hospital of Hefei	Hefei	Anhui
China	Jinan Central Hospital	Jinan	Shandong
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Affiliated Hospital of Jining Medical University	Jining City	Shandong
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	The Second Affiliated hospital of Kunming Medical University	Kunming	Yunnan
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The Second People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	The Second People's Hospital of Lianyungang	Lianyungang	Jiangsu
China	Liaocheng people's Hospital	Liaocheng
China	Liaocheng people's Hospital	Liaocheng	Shandong
China	Linyi People's Hospital	Linyi City	Shandong
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Qingdao Central Hospital	Qingdao	Shandong
China	Qingdao Central Hospital	Qingdao	Shandong
China	People's Hospital of Rizhao	Rizhao City	Shandong
China	Huashan Hospital Fudan University	Shanghai	Shanghai
China	Shanghai East Hospital	Shanghai	Shanghai
China	The People's Hospital of Liaoning Province	Shenyang	Liaoning
China	Hebei General Hospital	Shijiazhuang	Hebei
China	Hebei General Hospital	Shijiazhuang	Hebei
China	The First Affiliated Hospital of Suzhou University	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Tianjin Union Medical Center	Tianjin
China	The First Affiliated Hosptial of Wenzhou Medical University	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University	Wuhan City	Hubei
China	Wuxi No. 2 People's Hospital	Wuxi	Jiangsu
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	Shaanxi Provincial People's Hospital	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Xianyang Hospital of Yan'an University	Xianyang
China	Xianyang Hospital of Yan'an University	Xianyang	Shaanxi
China	Subei People's Hospital of Jiangsu province	Yangzhou	Jiangsu
China	General Hospital of Ningxia Medical Hospital	Yinchuan	NING XIA Province
China	People's Hospital of Zhengzhou	Zhengzhou	Henan
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from the Observation Phase (OP) in the number of migraine days per month over the entire Double Blind Treatment (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).	OP (up to 4 weeks) and Weeks 1-12 of the DBT phase
Secondary	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	A reduction of at least 50% in the mean number of moderate or severe monthly migraine days was determined if the number of moderate or severe monthly migraine days in the 12 weeks of the DBT (Weeks 1 to 12) is less than or equal to half (50%) of the number of moderate or severe monthly migraine days in the OP (up to 4 weeks).	OP (up to 4 weeks) and Weeks 1-12 of the DBT phase
Secondary	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.	The change from OP (up to 4 weeks) is calculated as the number of monthly migraine days during the first 4 weeks of the DBT phase (Weeks 1 to 4) minus number of monthly migraine days during the OP (up to 4 weeks).	OP (up to 4 weeks) and Weeks 1-4 of the DBT phase
Secondary	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.	The change from OP (up to 4 weeks) is calculated as the number of monthly migraine days during the last 4 weeks of the DBT phase (Weeks 9 to 12) minus number of monthly migraine days during the OP (up to 4 weeks).	OP (up to 4 weeks) and Weeks 9-12 of the DBT phase
Secondary	Mean change from baseline in the MSQoL v2.1 role function - restrictive domain score at Week 12 of the DBT Phase	The change from baseline was calculated as the MSQoL restrictive role function domain score at Week 12 of the DBT phase minus the MSQoL restrictive role function domain score at baseline.	OP (up to 4 weeks) and Week 12 of the DBT phase
Secondary	Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation during the DBT Phase and OLE Phase.	An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational product and that did not necessarily have a causal relationship with this treatment. An SAE is defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received an investigational product; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.	Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Secondary	Percentage of participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation during the DBT Phase and OLE Phase.	An AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition on-treatment in a patient or clinical investigation participant administered an investigational product and that did not necessarily have a causal relationship with this treatment. An SAE is defined as any event that met any of the following criteria: death; life-threatening; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect in the offspring of a participant who received an investigational product; other important medical events that may not have resulted in death, be life-threatening, or required hospitalization, based upon appropriate medical judgment, they may have jeopardized the participant and may have required medical or surgical intervention.	Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Secondary	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.	Elevations of AST > 3 x ULN concurrent with TBL > 2 x ULN were defined as elevations on the same collection date.	Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Secondary	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.	Elevations of AST > 3 x ULN concurrent with TBL > 2 x ULN were defined as elevations on the same collection date.	Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Secondary	Number of participants with hepatic-related AEs on treatment during the DBT Phase and OLE Phase.	Hepatic AEs are defined as all preferred terms under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those preferred terms in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ.	Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Secondary	Percentage of participants with hepatic-related AEs on treatment during the DBT Phase and OLE Phase.	Hepatic AEs are defined as all preferred terms under the "Hepatic Disorders" Standardized Medical Dictionary (Version 21.1) for Regulatory Activities Query (SMQ), except those preferred terms in the "Congenital, Familial, Neonatal and Genetic Disorders of the Liver" SMQ.	Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase

External Links

•   To obtain contact information for a study center near you, click here.
•   To obtain contact information for a study center near you, click here.