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| ID | Type | Description | Link |
|---|---|---|---|
| C4951018 | Other Identifier | Alias Study Number |
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This trial is to evaluate the long-term safety and tolerability of Rimegepant 75mg ODT in Chinese subjects with migraine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimegepant 75mg Orally Disintegrating Tablets (ODT) | Experimental | One rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant 75mg Orally Disintegrating Tablets (ODT) | Drug | One rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day) at the time of their migraine attack |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily have a causal relationship with the investigational product. TEAEs were events that started after the first dose of trial drug and did not occur or worsen relative to the first dose. | From Day 1 of study treatment up to Week 52 of the treatment safety period |
| Follow-up Safety Period: Number of Participants With TEAEs | An adverse event was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily have a causal relationship with the investigational product. TEAEs were events that started after the first dose of trial drug and did not occur or worsen relative to the first dose. | From Week 52 to Week 54 of the follow-up safety period |
| Treatment Safety Period: Number of Participants With Serious Adverse Events (SAEs) | An adverse event was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily have a causal relationship with the investigational product. SAE referred to any untoward medical occurrence that met any of the following criteria at any dose for a participant that received the investigational product: death, life-threatening, permanent or severe disability or incapacity, hospitalization or prolongation of hospitalization required or congenital anomaly or birth defect. | From Day 1 of study treatment up to Week 52 of the treatment safety period |
| Follow-up Safety Period: Number of Participants With SAEs | An adverse event was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily have a causal relationship with the investigational product. SAE referred to any untoward medical occurrence that met any of the following criteria at any dose for a participant that received the investigational product: death, life-threatening, permanent or severe disability or incapacity, hospitalization or prolongation of hospitalization required or congenital anomaly or birth defect. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period | The number of migraine days and severity of migraine attacks was analyzed for every 4-week interval and overall period during long-term treatment with rimegepant in participants was compared to the observation period. Pain intensity of migraine was graded into mild, moderate, or severe and severity was judged by investigator. |
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Inclusion Criteria:
At least a one-year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition beta version, including the following:
Age and Reproductive Status:
Exclusion Criteria:
Target Disease Exclusion:
* Subjects has a history of basilar migraine with brain stem aura or hemiplegic migraine
Medical History and Comorbidities:
Subjects who are positive for amphetamines on the urine drug screen may have their urine samples evaluated for further analysis at the investigator's discretion to rule out a false positive result
Allergy and Adverse Reactions:
*. History of drug or other allergy that, in the opinion of the investigator, would make the subject unsuitable for participation in the study
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China | ||
| Beijing Friendship Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41066271 | Derived | Zhang M, Guo A, Wu J, Wang H, Zhang Y, Dong H, Liu J, Zhang B, Guo H, Yu T, Lu Z, Ma L, Fountaine RJ, Pixton GC, Zhong Q, Han X, Yu S. Rimegepant for the acute treatment of migraine: A phase 3, multicenter, open-label, long-term safety and effectiveness study in adults from China. Cephalalgia. 2025 Oct;45(10):3331024251371686. doi: 10.1177/03331024251371686. Epub 2025 Oct 9. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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A total of 241 participants were enrolled in the study. 240 participants received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rimegepant 75 Milligrams (mg) Orally Disintegrating Tablets (ODT) | Chinese participants with migraine received 75 mg of rimegepant ODT (Pro re nata [PRN] use, up to 1 tablet per day) for 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2023 | Jan 28, 2025 |
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| From Week 52 to Week 54 of the follow-up safety period |
| Treatment Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation | An AE was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily had a causal relationship with the investigational product. AEs that led to study drug discontinuation were reported in this outcome measure. | From Day 1 of study treatment up to Week 52 of the treatment safety period |
| Follow-up Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation | An AE was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily had a causal relationship with the investigational product. AEs that led to study drug discontinuation were reported in this outcome measure. | From Week 52 to Week 54 of the follow-up safety period |
| Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities criteria included: QT Interval Corrected Using Fridericia's Formula (QTcF) millisecond (msec): less than or equal to (<=)450, 450 - <=480, 480- <=500, greater than (>)500. | From Day 1 of study treatment up to Week 52 of the treatment safety period |
| Follow-up Safety Period: Number of Participants With ECG Abnormalities | ECG abnormalities criteria included: QTcF msec: <=450, 450 - <=480, 480- <=500, >500. | From Week 52 to Week 54 of the follow-up safety period |
| Treatment Safety Period: Number of Participants With Vital Signs Abnormalities | Vital signs abnormalities included blood pressure (BP) millimeters of mercury (mmHg): systolic BP <90 and >140; diastolic BP <50 and >90 and pulse rate (beats per minute) :<40 and >120. | From Day 1 of study treatment up to Week 52 of the treatment safety period |
| Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. | Vital signs abnormalities included BP mmHg: systolic BP <90 and >140; diastolic BP <50 and >90 and pulse rate (beats per minute) :<40 and >120. | From Week 52 to Week 54 of the follow-up safety period |
| Treatment Safety Period: Number of Participants With Hematology Test Abnormalities | Hematology parameters included: hemoglobin increased, anemia, leukocytosis, white blood cell decreased, platelet count decreased, neutrophil count decreased, lymphocyte count increased, lymphocyte count decreased. As per National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version(v)5.0-Grade(G) 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: moderate; minimal, local or non-invasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL), Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. Grade 3 and 4 abnormalities were reported in this outcome measure. | From Day 1 of study treatment up to Week 52 of the treatment safety period |
| Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities | Hematology parameters included: hemoglobin increased, anemia, leukocytosis, white blood cell decreased, platelet count decreased, neutrophil count decreased, lymphocyte count increased, lymphocyte count decreased. As per NCI CTCAE v5.0-Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. Grade 3 and 4 abnormalities were reported in this outcome measure. | From Week 52 to Week 54 of the follow-up safety period |
| Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities | Chemistry Test Abnormalities included: hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypoglycemia, creatinine increased, blood lactate dehydrogenase increased, hypoalbuminemia, creatine phosphokinase (CPK) increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, alkaline phosphatase increased, chronic kidney disease, cholesterol high, hypertriglyceridemia. As per NCI CTCAE v5.0-G1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, G2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental ADL, G3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. G4: life-threatening consequences; urgent intervention indicated. G5: death related to AE. G3 and 4 abnormalities were reported in this outcome measure. | From Day 1 of study treatment up to Week 52 of the treatment safety period |
| Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities | Chemistry Test Abnormalities included: hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypoglycemia, creatinine increased, blood lactate dehydrogenase increased, hypoalbuminemia, CPK increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, alkaline phosphatase increased, chronic kidney disease, cholesterol high, hypertriglyceridemia. As per NCI CTCAE v5.0-G1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, G2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental ADL, G3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. G4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. G3 and 4 abnormalities were reported in this outcome measure. | From Week 52 to Week 54 of the follow-up safety period |
| Baseline (observation period); Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52 and Overall (Week 1 to 52) |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100089 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
| The First Affiliated hospital of Xiamen University | Xiamen | Fujian | 361003 | China |
| Hainan General Hospital | Haikou | Hainan | 570311 | China |
| Hebei General Hospital | Shijiazhuang | Hebei | 050051 | China |
| Renmin Hospital Of Wuhan University | Wuhan | Hubei | 430060 | China |
| Wuhan Third Hospital | Wuhan | Hubei | 430074 | China |
| Changsha Central Hospital | Changsha | Hunan | 410000 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410000 | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | 130000 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | 130041 | China |
| General Hospital of Northern Theater Command | Shenyang | Liaoning | 110801 | China |
| Shaanxi Provincial People' Hospital | Xi'an | Shaanxi | 710068 | China |
| The First Affiliated Hospital of Xi'an Medical University | Xi'an | Shaanxi | 710082 | China |
| Yan'an University Xianyang Hospital Co., Ltd | Xianyang | Shaanxi | 712000 | China |
| LiaoCheng People's Hospital | Liaocheng | Shandong | 252000 | China |
| Tongji Hospital of Tongji University | Shanghai | Shanghai Municipality | 200065 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610000 | China |
| The Second Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 8320000 | China |
| The Second Affiliated hospital of Kunming Medical University | Kunming | Yunnan | 650000 | China |
| Peking University People's Hospital | Beijing | 100044 | China |
| Guangzhou First People's Hospital | Guangzhou | 510180 | China |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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Full Analysis set included all participants who were enrolled and received at least one dose of the investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Rimegepant 75mg ODT | Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) | An adverse event was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily have a causal relationship with the investigational product. TEAEs were events that started after the first dose of trial drug and did not occur or worsen relative to the first dose. | Safety analysis set (SS) included all participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | From Day 1 of study treatment up to Week 52 of the treatment safety period |
|
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| ||||||||||||||||||||||||||
| Primary | Follow-up Safety Period: Number of Participants With TEAEs | An adverse event was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily have a causal relationship with the investigational product. TEAEs were events that started after the first dose of trial drug and did not occur or worsen relative to the first dose. | Follow-up safety analysis set (FUSS) included all participants in the SS with last contact date in the follow-up safety analysis period. | Posted | Count of Participants | Participants | From Week 52 to Week 54 of the follow-up safety period |
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| Primary | Treatment Safety Period: Number of Participants With Serious Adverse Events (SAEs) | An adverse event was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily have a causal relationship with the investigational product. SAE referred to any untoward medical occurrence that met any of the following criteria at any dose for a participant that received the investigational product: death, life-threatening, permanent or severe disability or incapacity, hospitalization or prolongation of hospitalization required or congenital anomaly or birth defect. | Safety analysis set included all participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | From Day 1 of study treatment up to Week 52 of the treatment safety period |
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| Primary | Follow-up Safety Period: Number of Participants With SAEs | An adverse event was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily have a causal relationship with the investigational product. SAE referred to any untoward medical occurrence that met any of the following criteria at any dose for a participant that received the investigational product: death, life-threatening, permanent or severe disability or incapacity, hospitalization or prolongation of hospitalization required or congenital anomaly or birth defect. | FUSS included all participants in the SS with last contact date in the follow-up safety analysis period. | Posted | Count of Participants | Participants | From Week 52 to Week 54 of the follow-up safety period |
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| Primary | Treatment Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation | An AE was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily had a causal relationship with the investigational product. AEs that led to study drug discontinuation were reported in this outcome measure. | Safety analysis set included all participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | From Day 1 of study treatment up to Week 52 of the treatment safety period |
|
| |||||||||||||||||||||||||||
| Primary | Follow-up Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation | An AE was any untoward medical occurrence in a clinical trial participant administered an investigational product that may present with symptoms/signs, disease, or laboratory abnormalities and which did not necessarily had a causal relationship with the investigational product. AEs that led to study drug discontinuation were reported in this outcome measure. | FUSS included all participants in the SS with last contact date in the follow-up safety analysis period. | Posted | Count of Participants | Participants | From Week 52 to Week 54 of the follow-up safety period |
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| Primary | Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities | ECG abnormalities criteria included: QT Interval Corrected Using Fridericia's Formula (QTcF) millisecond (msec): less than or equal to (<=)450, 450 - <=480, 480- <=500, greater than (>)500. | Safety analysis set included all participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | From Day 1 of study treatment up to Week 52 of the treatment safety period |
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| Primary | Follow-up Safety Period: Number of Participants With ECG Abnormalities | ECG abnormalities criteria included: QTcF msec: <=450, 450 - <=480, 480- <=500, >500. | FUSS included all participants in the SS with last contact date in the follow-up safety analysis period. | Posted | Count of Participants | Participants | From Week 52 to Week 54 of the follow-up safety period |
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| Primary | Treatment Safety Period: Number of Participants With Vital Signs Abnormalities | Vital signs abnormalities included blood pressure (BP) millimeters of mercury (mmHg): systolic BP <90 and >140; diastolic BP <50 and >90 and pulse rate (beats per minute) :<40 and >120. | Safety analysis set included all participants who received at least one dose of investigational product. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Day 1 of study treatment up to Week 52 of the treatment safety period |
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| Primary | Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. | Vital signs abnormalities included BP mmHg: systolic BP <90 and >140; diastolic BP <50 and >90 and pulse rate (beats per minute) :<40 and >120. | FUSS included all participants in the SS with last contact date in the follow-up safety analysis period. Here, "Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | From Week 52 to Week 54 of the follow-up safety period |
|
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| Primary | Treatment Safety Period: Number of Participants With Hematology Test Abnormalities | Hematology parameters included: hemoglobin increased, anemia, leukocytosis, white blood cell decreased, platelet count decreased, neutrophil count decreased, lymphocyte count increased, lymphocyte count decreased. As per National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) version(v)5.0-Grade(G) 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: moderate; minimal, local or non-invasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL), Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. Grade 3 and 4 abnormalities were reported in this outcome measure. | Safety analysis set included all participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | From Day 1 of study treatment up to Week 52 of the treatment safety period |
|
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| Primary | Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities | Hematology parameters included: hemoglobin increased, anemia, leukocytosis, white blood cell decreased, platelet count decreased, neutrophil count decreased, lymphocyte count increased, lymphocyte count decreased. As per NCI CTCAE v5.0-Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, Grade 2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental ADL, Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. Grade 3 and 4 abnormalities were reported in this outcome measure. | FUSS included all participants in the SS with last contact date in the follow-up safety analysis period. | Posted | Count of Participants | Participants | From Week 52 to Week 54 of the follow-up safety period |
|
| |||||||||||||||||||||||||||
| Primary | Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities | Chemistry Test Abnormalities included: hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypoglycemia, creatinine increased, blood lactate dehydrogenase increased, hypoalbuminemia, creatine phosphokinase (CPK) increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, alkaline phosphatase increased, chronic kidney disease, cholesterol high, hypertriglyceridemia. As per NCI CTCAE v5.0-G1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, G2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental ADL, G3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. G4: life-threatening consequences; urgent intervention indicated. G5: death related to AE. G3 and 4 abnormalities were reported in this outcome measure. | Safety analysis set included all participants who received at least one dose of investigational product. | Posted | Count of Participants | Participants | From Day 1 of study treatment up to Week 52 of the treatment safety period |
| ||||||||||||||||||||||||||||
| Primary | Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities | Chemistry Test Abnormalities included: hypernatremia, hyponatremia, hyperkalemia, hypokalemia, hypoglycemia, creatinine increased, blood lactate dehydrogenase increased, hypoalbuminemia, CPK increased, aspartate aminotransferase increased, alanine aminotransferase increased, blood bilirubin increased, alkaline phosphatase increased, chronic kidney disease, cholesterol high, hypertriglyceridemia. As per NCI CTCAE v5.0-G1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated, G2: moderate; minimal, local or non-invasive intervention indicated; limiting age-appropriate instrumental ADL, G3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. G4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE. G3 and 4 abnormalities were reported in this outcome measure. | FUSS included all participants in the SS with last contact date in the follow-up safety analysis period. | Posted | Count of Participants | Participants | From Week 52 to Week 54 of the follow-up safety period |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period | The number of migraine days and severity of migraine attacks was analyzed for every 4-week interval and overall period during long-term treatment with rimegepant in participants was compared to the observation period. Pain intensity of migraine was graded into mild, moderate, or severe and severity was judged by investigator. | Efficacy analysis set (EAS) included all participants in the FAS with>= 14 electronic (e)Diary days (not necessarily consecutive) in both the observational period analysis period and>= 1 month (4-week interval) of the long-term treatment analysis period. "Number Analyzed" signifies number of participants evaluable for the specified rows. | Posted | Mean | Standard Deviation | Days | Baseline (observation period); Week 1 to 4, 5 to 8, 9 to 12, 13 to 16, 17 to 20, 21 to 24, 25 to 28, 29 to 32, 33 to 36, 37 to 40, 41 to 44, 45 to 48, 49 to 52 and Overall (Week 1 to 52) |
|
|
From Day 1 of study treatment up to Week 54
Same event may appear as both non-SAE and SAE but what is presented are distinct events. An event may be categorized as serious in one participant and non-serious in another participant or one participant may have experienced both serious and non-serious event. Safety analysis set included all participants who received at least one dose of investigational product. The SS used for safety analyses during treatment safety period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rimegepant 75 mg ODT | Chinese participants with migraine received 75 mg of rimegepant ODT (PRN use, up to 1 tablet per day) for 52 weeks. | 1 | 240 | 7 | 240 | 201 | 240 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA26.1 | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA26.1 | Non-systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Benign breast neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA26.1 | Non-systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Varicose vein | Vascular disorders | MedDRA26.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA26.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA26.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA26.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA26.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA26.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA26.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA26.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA26.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA26.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA26.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA26.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA26.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Sinus arrhythmia | Cardiac disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA26.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA26.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2024 | Jan 28, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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