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

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Rimegepant
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Rimegepent, preventive treatment, migraine.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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. Exclusion Criteria: Participant has a history of basilar migraine or hemiplegic migraine. Participants with headaches occurring 19 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit. 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.

Sites / Locations

  • The Second People's hospital of HefeiRecruiting
  • Beijing Friendship Hospital, Capital Medical UniversityRecruiting
  • Chinese PLA General HospitalRecruiting
  • Chinese PLA General Hospital
  • The fourth people's hospital of chongqingRecruiting
  • The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
  • The 900th Hospital of Joint Logistics Support Force, PLARecruiting
  • Lanzhou University Second Hospital
  • Guangzhou First People's Hospital
  • Hainan General HospitalRecruiting
  • Hebei General Hospital
  • People's Hospital of ZhengzhouRecruiting
  • Renmin Hospital of Wuhan University
  • The Third Xiangya Hospital of Central South University
  • The Third Xiangya Hospital of Central South UniversityRecruiting
  • The First Affiliated Hospital of Baotou Medical CollegeRecruiting
  • The Second People's Hospital of Lianyungang
  • The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting
  • The Second Affiliated Hospital of Soochow UniversityRecruiting
  • The First Affiliated Hospital of Suzhou UniversityRecruiting
  • The Second Affiliated Hospital of Soochow University
  • Wuxi People's HospitalRecruiting
  • Wuxi No. 2 People's HospitalRecruiting
  • Subei People's Hospital of Jiangsu province
  • Affiliated Hospital of Jiangsu UniversityRecruiting
  • Pingxiang People's HospitalRecruiting
  • Pingxiang People's HospitalRecruiting
  • The first hospital of Jilin University
  • The Second Hospital of Jilin UniversityRecruiting
  • The People's Hospital of Liaoning ProvinceRecruiting
  • General Hospital of Ningxia Medical Hospital
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shaanxi Provincial People's Hospital
  • Xianyang Hospital of Yan'an UniversityRecruiting
  • Shengli Oilfield Central Hospital
  • Qilu Hospital of Shandong UniversityRecruiting
  • Jinan Central HospitalRecruiting
  • Affiliated Hospital of Jining Medical UniversityRecruiting
  • Liaocheng people's HospitalRecruiting
  • Linyi People's HospitalRecruiting
  • Qingdao Central Hospital
  • Qingdao Central HospitalRecruiting
  • People's Hospital of RizhaoRecruiting
  • Huashan Hospital Fudan UniversityRecruiting
  • Shanghai East HospitalRecruiting
  • The First Hospital of Shanxi Medical UniversityRecruiting
  • The Second Affiliated hospital of Kunming Medical University
  • First Affiliated Hospital of Kunming Medical University
  • Sir Run Run Shaw HospitalRecruiting
  • The First Affiliated Hosptial of Wenzhou Medical University
  • Peking University People's HospitalRecruiting
  • Heping Hospital Affiliated to Changzhi Medical College
  • Heping Hospital Affiliated to Changzhi Medical College
  • Chongqing University Three Gorges HospitalRecruiting
  • Liaocheng people's HospitalRecruiting
  • Tianjin Union Medical CenterRecruiting
  • Xianyang Hospital of Yan'an UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DBT Rimegepant/OLE Rimegepant

DBT Placebo/OLE Rimegepant

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).
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).
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 30, 2023
Last Updated
October 4, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05810038
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
September 4, 2025 (Anticipated)
Study Completion Date
December 13, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Rimegepent, preventive treatment, migraine.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
784 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DBT Rimegepant/OLE Rimegepant
Arm Type
Experimental
Arm Description
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).
Arm Title
DBT Placebo/OLE Rimegepant
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Rimegepant
Other Intervention Name(s)
PF-07899801, BHV-3000
Intervention Description
Rimegepant
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Mean change from the Observation Phase (OP) in the number of migraine days per month over the entire Double Blind Treatment (DBT) Phase
Description
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).
Time Frame
OP (up to 4 weeks) and Weeks 1-12 of the DBT phase
Secondary Outcome Measure Information:
Title
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
Description
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).
Time Frame
OP (up to 4 weeks) and Weeks 1-12 of the DBT phase
Title
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.
Description
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).
Time Frame
OP (up to 4 weeks) and Weeks 1-4 of the DBT phase
Title
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.
Description
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).
Time Frame
OP (up to 4 weeks) and Weeks 9-12 of the DBT phase
Title
Mean change from baseline in the MSQoL v2.1 role function - restrictive domain score at Week 12 of the DBT Phase
Description
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.
Time Frame
OP (up to 4 weeks) and Week 12 of the DBT phase
Title
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation during the DBT Phase and OLE Phase.
Description
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.
Time Frame
Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Title
Percentage of participants With Adverse Events (AEs), Serious AEs (SAEs) and AEs Leading to Study Drug Discontinuation during the DBT Phase and OLE Phase.
Description
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.
Time Frame
Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Title
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.
Description
Elevations of AST > 3 x ULN concurrent with TBL > 2 x ULN were defined as elevations on the same collection date.
Time Frame
Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Title
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.
Description
Elevations of AST > 3 x ULN concurrent with TBL > 2 x ULN were defined as elevations on the same collection date.
Time Frame
Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Title
Number of participants with hepatic-related AEs on treatment during the DBT Phase and OLE Phase.
Description
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.
Time Frame
Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase
Title
Percentage of participants with hepatic-related AEs on treatment during the DBT Phase and OLE Phase.
Description
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.
Time Frame
Weeks 1-12 of the DBT phase, and Weeks 13-24 of the OLE phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 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. Exclusion Criteria: Participant has a history of basilar migraine or hemiplegic migraine. Participants with headaches occurring 19 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
The Second People's hospital of Hefei
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230011
Country
China
Individual Site Status
Recruiting
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The fourth people's hospital of chongqing
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Individual Site Status
Recruiting
Facility Name
The 900th Hospital of Joint Logistics Support Force, PLA
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China
Individual Site Status
Recruiting
Facility Name
Lanzhou University Second Hospital
City
Lanzhou
State/Province
Gansu
ZIP/Postal Code
730030
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Individual Site Status
Recruiting
Facility Name
Hebei General Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Not yet recruiting
Facility Name
People's Hospital of Zhengzhou
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450014
Country
China
Individual Site Status
Recruiting
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan City
State/Province
Hubei
ZIP/Postal Code
430060
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Baotou Medical College
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Individual Site Status
Recruiting
Facility Name
The Second People's Hospital of Lianyungang
City
Lianyungang
State/Province
Jiangsu
ZIP/Postal Code
222006
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Suzhou University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215025
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Individual Site Status
Recruiting
Facility Name
Wuxi No. 2 People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214043
Country
China
Individual Site Status
Recruiting
Facility Name
Subei People's Hospital of Jiangsu province
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Affiliated Hospital of Jiangsu University
City
Zhenjiang
State/Province
Jiangsu
ZIP/Postal Code
212001
Country
China
Individual Site Status
Recruiting
Facility Name
Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Individual Site Status
Recruiting
Facility Name
Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
Country
China
Individual Site Status
Recruiting
Facility Name
The first hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Name
The People's Hospital of Liaoning Province
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110067
Country
China
Individual Site Status
Recruiting
Facility Name
General Hospital of Ningxia Medical Hospital
City
Yinchuan
State/Province
NING XIA Province
ZIP/Postal Code
750003
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shaanxi Provincial People's Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Xianyang Hospital of Yan'an University
City
Xianyang
State/Province
Shaanxi
ZIP/Postal Code
712000
Country
China
Individual Site Status
Recruiting
Facility Name
Shengli Oilfield Central Hospital
City
Dongying
State/Province
Shandong
ZIP/Postal Code
257099
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Jining Medical University
City
Jining City
State/Province
Shandong
ZIP/Postal Code
272000
Country
China
Individual Site Status
Recruiting
Facility Name
Liaocheng people's Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China
Individual Site Status
Recruiting
Facility Name
Linyi People's Hospital
City
Linyi City
State/Province
Shandong
ZIP/Postal Code
276034
Country
China
Individual Site Status
Recruiting
Facility Name
Qingdao Central Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266042
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Qingdao Central Hospital
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266042
Country
China
Individual Site Status
Recruiting
Facility Name
People's Hospital of Rizhao
City
Rizhao City
State/Province
Shandong
ZIP/Postal Code
276800
Country
China
Individual Site Status
Recruiting
Facility Name
Huashan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai East Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
Individual Site Status
Recruiting
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Sir Run Run Shaw Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hosptial of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Peking University People's Hospital
City
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
Heping Hospital Affiliated to Changzhi Medical College
City
Changzhi City
ZIP/Postal Code
046000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Heping Hospital Affiliated to Changzhi Medical College
City
Changzhi City
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Chongqing University Three Gorges Hospital
City
Chongqing
ZIP/Postal Code
404000
Country
China
Individual Site Status
Recruiting
Facility Name
Liaocheng people's Hospital
City
Liaocheng
ZIP/Postal Code
252004
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Union Medical Center
City
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Name
Xianyang Hospital of Yan'an University
City
Xianyang
ZIP/Postal Code
712000
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C4951019
Description
To obtain contact information for a study center near you, click here.
URL
https://pmiform.com/clinical-trial-info-request?StudyID=BHV3000-319
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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