A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.
Migraine
About this trial
This is an interventional treatment trial for Migraine focused on measuring Rimegepent, preventive treatment, migraine.
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.
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
Experimental
Placebo Comparator
DBT Rimegepant/OLE Rimegepant
DBT Placebo/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).
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).