A Study to Learn About the Safety and Effects of Rimegepant to Prevent Migraine in Chinese Subjects.
Study Details
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:
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Are male and female of 18 years of age or older.
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Have at least 1 year history of migraine .
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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). |
Drug: Rimegepant
Rimegepant
Other Names:
|
| Placebo Comparator: 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). |
Drug: Rimegepant
Rimegepant
Other Names:
Drug: Placebo
matching placebo
|
Outcome Measures
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 [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).
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 [OP (up to 4 weeks) and Weeks 1-12 of the 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. [OP (up to 4 weeks) and Weeks 1-4 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. [OP (up to 4 weeks) and Weeks 9-12 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 [OP (up to 4 weeks) and 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. [Weeks 1-12 of the DBT phase, and Weeks 13-24 of the 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. [Weeks 1-12 of the DBT phase, and Weeks 13-24 of the 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. [Weeks 1-12 of the DBT phase, and Weeks 13-24 of the 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. [Weeks 1-12 of the DBT phase, and Weeks 13-24 of the 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. [Weeks 1-12 of the DBT phase, and Weeks 13-24 of the 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. [Weeks 1-12 of the DBT phase, and Weeks 13-24 of the 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.
Eligibility Criteria
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:
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Age of onset of migraines prior to 50 years of age
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Migraine attacks, on average, lasting 4 to 72 hours if untreated
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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)
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6 or more migraine days during Observation Phase
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Not more than 18 headache days during the Observation Phase
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Ability to distinguish migraine attacks from tension/cluster headaches.
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Participants with contraindications for use of triptans may be included provided they meet all other study entry criteria.
Exclusion Criteria:
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Participant has a history of basilar migraine or hemiplegic migraine.
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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.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Pfizer
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- BHV3000-319
- C4951019