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CompletedNCT05371652Updated Feb 20, 2025Results posted

A Study to Learn About the Long-term Safety of Rimegepant for the Acute Treatment of Migraine in Chinese Participants

A Phase 3 interventional study of Rimegepant 75mg Orally Disintegrating Tablets (ODT) in Acute Migraine, sponsored by Pfizer. Completed at 26 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
241
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This trial is to evaluate the long-term safety and tolerability of Rimegepant 75mg ODT in Chinese subjects with migraine

02

Conditions studied

  • Acute Migraine

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Keywords

  • Migraine
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 241 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 of onset of migraines prior to 50 years of age
  • Migraine attacks, on average, lasting 4 - 72 hours if untreated
  • 6-18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit
  • 6 or more migraine days requiring treatment during Observation Phase
  • Ability to distinguish migraine attacks from tension/cluster headaches
  • Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable dose for at least 2 months prior to the Baseline Visit, and the dose is not expected to change during the course of the study. subjects who previously discontinued prophylactic migraine medication must have done so at least 5 half-lives of the prophylactic medication prior to the Screening Visit
  • Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria

Age and Reproductive Status:

  • Male or female subjects ≥ 18 years
  • Women of childbearing potential (WOCBP) must voluntarily use 1 acceptable methods of contraception to avoid pregnancy and to minimize the risk of pregnancy from signing of informed consent through 28 days after study drug administration. WOCBP is defined in Section 12.3. No contraception methods are required for male subjects in this study.

Exclusion criteria

Exclusion Criteria:

Target Disease Exclusion:

* Subjects has a history of basilar migraine with brain stem aura or hemiplegic migraine

Medical History and Comorbidities:

  • History of HIV disease
  • Current evidence of poorly controlled, unstable, or recently diagnosed cardiovascular or cerebrovascular disease such as ischemic heart disease, coronary vasospasm, and cerebral ischemia. Myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke, or transient ischemic attack (TIA) during 6 months prior to screening
  • Poorly controlled hypertension (high blood pressure) or poorly controlled diabetes (but subjects with stable hypertension and/or diabetes for at least 3 months prior to screening may be included in the study). Blood pressure greater than 150 mmHg systolic or 100 mmHg diastolic after 10 minutes of rest is exclusionary
  • Subjects with a current diagnosis of major depression or a major depressive episode within the last 12 months, other pain syndromes, psychiatric disorders, dementia, or significant neurological disorders (other than migraine) that, in the opinion of the investigator, might interfere with study assessments
  • History of gastric or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric water ball, etc.) or diseases resulting in malabsorption
  • Subject has a history or diagnosis of Gilibert's Syndrome or any other active hepatic or biliary disorder
  • History or presence of significant and/or unstable medical conditions (e.g., history of congenital heart disease or cardiac arrhythmia, known suspected infection, hepatitis B or C or neoplasm) that, in the opinion of the investigator, would expose the subjects to undue risk of a significant adverse events (AE) or interfere with the assessment of safety or effectiveness during the trial
  • History or evidence of alcohol or drug abuse within the past 12 months, or treatment for alcohol or drug abuse, or meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for any significant substance abuse disorder within the past 12 months prior to the Screening Visit
  • Subjects should be excluded if they have a positive drug screen for drugs of abuse and are considered medically significant by the investigator, would compromise subject safety, or interfere with the interpretation of study results. In addition:
  • Subjects with detectable levels of cocaine, amphetamines, and phencyclidine in drug abuse screening need to be excluded.

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

  • Subjects with detectable levels of marijuana during substance abuse screening may not be excluded if they do not meet DSMV criteria for substance abuse or dependence in the subject's opinion as documented by the investigator, and a positive result does not signal a clinical condition that would impact the subject safety or interpretation of the study results
  • Diagnosis of hematologic or solid malignancy within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer may be included in the study if they are cancer-free prior to the screening visit for this study
  • Subjects with a current diagnosis of schizophrenia, major depression requiring treatment with atypical antipsychotics, bipolar disorder or borderline personality disorder
  • Body mass index (BMI) ≥ 35 kg/ m2
  • Subjects with a history of gallstones or cholecystectomy
  • Use of St. John's Wort, products containing St. John's Wort, Coltsfoot root, or extracts within 14 days prior to the baseline visit
  • Use of narcotic drugs such as opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) within 2 days prior to the baseline visit.

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

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
241 participants (actual)

Study arms

  • Experimental
    Rimegepant 75mg Orally Disintegrating Tablets (ODT)

    One rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day)

    Drug: Rimegepant 75mg Orally Disintegrating Tablets (ODT)

Interventions

  • DrugRimegepant 75mg Orally Disintegrating Tablets (ODT)

    One rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day) at the time of their migraine attack

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From Day 1 of study treatment up to Week 52 of the treatment safety period

  2. 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.

    Time frame: From Week 52 to Week 54 of the follow-up safety period

  3. 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.

    Time frame: From Day 1 of study treatment up to Week 52 of the treatment safety period

  4. 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.

    Time frame: From Week 52 to Week 54 of the follow-up safety period

  5. 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.

    Time frame: From Day 1 of study treatment up to Week 52 of the treatment safety period

  6. 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.

    Time frame: From Week 52 to Week 54 of the follow-up safety period

  7. 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.

    Time frame: From Day 1 of study treatment up to Week 52 of the treatment safety period

  8. Follow-up Safety Period: Number of Participants With ECG Abnormalities

    ECG abnormalities criteria included: QTcF msec: \<=450, 450 - \<=480, 480- \<=500, \>500.

    Time frame: From Week 52 to Week 54 of the follow-up safety period

  9. 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.

    Time frame: From Day 1 of study treatment up to Week 52 of the treatment safety period

  10. 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.

    Time frame: From Week 52 to Week 54 of the follow-up safety period

  11. 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.

    Time frame: From Day 1 of study treatment up to Week 52 of the treatment safety period

  12. 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.

    Time frame: From Week 52 to Week 54 of the follow-up safety period

  13. 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.

    Time frame: From Day 1 of study treatment up to Week 52 of the treatment safety period

  14. 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.

    Time frame: From Week 52 to Week 54 of the follow-up safety period

Secondary outcomes

  1. 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.

    Time frame: 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)

07

Results

Posted Feb 20, 2025

Participant flow

A total of 241 participants were enrolled in the study. 240 participants received study treatment.

Participant flow — Overall Study
MilestoneRimegepant 75 Milligrams (mg) Orally Disintegrating Tablets (ODT)
Started241
Treated240
Completed208
Not completed33
Withdrew: Non-compliance with study schedule9
Withdrew: Withdrawal by subject12
Withdrew: Adverse event1
Withdrew: Other11

Outcome measures

PrimaryTreatment 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.

Time frame:
From Day 1 of study treatment up to Week 52 of the treatment safety period
Reported as:
Count of participants · Participants
Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
ParticipantsRimegepant 75 mg ODT
Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs)203
PrimaryFollow-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.

Time frame:
From Week 52 to Week 54 of the follow-up safety period
Reported as:
Count of participants · Participants
Follow-up Safety Period: Number of Participants With TEAEs
ParticipantsRimegepant 75 mg ODT
Follow-up Safety Period: Number of Participants With TEAEs24
PrimaryTreatment 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.

Time frame:
From Day 1 of study treatment up to Week 52 of the treatment safety period
Reported as:
Count of participants · Participants
Treatment Safety Period: Number of Participants With Serious Adverse Events (SAEs)
ParticipantsRimegepant 75 mg ODT
Treatment Safety Period: Number of Participants With Serious Adverse Events (SAEs)7
PrimaryFollow-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.

Time frame:
From Week 52 to Week 54 of the follow-up safety period
Reported as:
Count of participants · Participants
Follow-up Safety Period: Number of Participants With SAEs
ParticipantsRimegepant 75 mg ODT
Follow-up Safety Period: Number of Participants With SAEs0
PrimaryTreatment 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.

Time frame:
From Day 1 of study treatment up to Week 52 of the treatment safety period
Reported as:
Count of participants · Participants
Treatment Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation
ParticipantsRimegepant 75 mg ODT
Treatment Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation1
PrimaryFollow-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.

Time frame:
From Week 52 to Week 54 of the follow-up safety period
Reported as:
Count of participants · Participants
Follow-up Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation
ParticipantsRimegepant 75 mg ODT
Follow-up Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation0
PrimaryTreatment 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.

Time frame:
From Day 1 of study treatment up to Week 52 of the treatment safety period
Reported as:
Count of participants · Participants
Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities
ParticipantsRimegepant 75 mg ODT
<=450225
450 - <= 4806
480 - <= 5000
> 5000
PrimaryFollow-up Safety Period: Number of Participants With ECG Abnormalities

ECG abnormalities criteria included: QTcF msec: \<=450, 450 - \<=480, 480- \<=500, \>500.

Time frame:
From Week 52 to Week 54 of the follow-up safety period
Reported as:
Count of participants · Participants
Follow-up Safety Period: Number of Participants With ECG Abnormalities
ParticipantsRimegepant 75 mg ODT
<=450209
450 - <= 4802
480 - <= 5000
>5002
PrimaryTreatment 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.

Time frame:
From Day 1 of study treatment up to Week 52 of the treatment safety period
Reported as:
Count of participants · Participants
Treatment Safety Period: Number of Participants With Vital Signs Abnormalities
ParticipantsRimegepant 75 mg ODT
Systolic BP <9012
Systolic BP >1409
Diastolic BP <501
Diastolic BP >9017
Pulse rate <400
Pulse rate >1200
PrimaryFollow-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.

Time frame:
From Week 52 to Week 54 of the follow-up safety period
Reported as:
Count of participants · Participants
Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities.
ParticipantsRimegepant 75 mg ODT
Systolic BP <901
Systolic BP >1401
Diastolic BP <500
Diastolic BP >905
Pulse rate <400
Pulse rate >1200
PrimaryTreatment 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.

Time frame:
From Day 1 of study treatment up to Week 52 of the treatment safety period
Reported as:
Count of participants · Participants
Treatment Safety Period: Number of Participants With Hematology Test Abnormalities
ParticipantsRimegepant 75 mg ODT
Hemoglobin increased0
Anemia1
Leukocytosis0
White blood cell decreased1
Platelet count decreased0
Neutrophil count decreased1
Lymphocyte count increased0
Lymphocyte count decreased1
PrimaryFollow-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.

Time frame:
From Week 52 to Week 54 of the follow-up safety period
Reported as:
Count of participants · Participants
Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities
ParticipantsRimegepant 75 mg ODT
Hemoglobin increased0
Anemia0
Leukocytosis0
White blood cell decreased0
Platelet count decreased0
Neutrophil count decreased1
Lymphocyte count increased0
Lymphocyte count decreased0
PrimaryTreatment 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.

Time frame:
From Day 1 of study treatment up to Week 52 of the treatment safety period
Reported as:
Count of participants · Participants
Treatment Safety Period: Number of Participants With Chemistry Test Abnormalities
ParticipantsRimegepant 75 mg ODT
Hypernatremia0
Hyponatremia0
Hyperkalemia0
Hypokalemia1
Hypoglycemia0
Creatinine increased0
Blood lactate dehydrogenase increased0
Hypoalbuminemia0
CPK increased4
Aspartate aminotransferase increased1
Alanine aminotransferase increased0
Blood bilirubin increased0
Alkaline phosphatase increased0
Chronic kidney disease0
Cholesterol high0
Hypertriglyceridemia2
PrimaryFollow-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.

Time frame:
From Week 52 to Week 54 of the follow-up safety period
Reported as:
Count of participants · Participants
Follow-up Safety Period: Number of Participants With Chemistry Test Abnormalities
ParticipantsRimegepant 75 mg ODT
Hypernatremia0
Hyponatremia0
Hyperkalemia0
Hypokalemia1
Hypoglycemia0
Creatinine increased0
Blood lactate dehydrogenase increased0
Hypoalbuminemia0
CPK increased0
Aspartate aminotransferase increased0
Alanine aminotransferase increased0
Blood bilirubin increased0
Alkaline phosphatase increased0
Chronic kidney disease0
Cholesterol high0
Hypertriglyceridemia0
SecondaryChange 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.

Time frame:
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)
Reported as:
Mean · Days
Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall Period
DaysRimegepant 75 mg ODT
Week 1 to Week 4-1.7 ± 3.8
Week 5 to Week 8-2.4 ± 4.5
Week 9 to Week 12-3.4 ± 4.2
Week 13 to Week 16-3.7 ± 4.6
Week 17 to Week 20-4.4 ± 4.6
Week 21 to Week 24-4.8 ± 4.6
Week 25 to Week 28-5.2 ± 4.6
Week 29 to Week 32-4.8 ± 4.7
Week 33 to Week 36-5.2 ± 4.5
Week 37 to Week 40-5.5 ± 5.1
Week 41 to Week 44-5.7 ± 4.7
Week 45 to Week 48-5.6 ± 4.7
Week 49 to Week 52-5.6 ± 5.5
Overall-2.8 ± 4.1

Adverse events

Collected over From Day 1 of study treatment up to Week 54. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Rimegepant 75 mg ODT1/240 (0.4%)7/240 (2.9%)201/240 (83.8%)
Most frequent serious events
Most frequent serious events
EventRimegepant 75 mg ODT
Arteriosclerosis coronary arteryCardiac disorders1/240
PneumoniaInfections and infestations1/240
Clavicle fractureInjury, poisoning and procedural complications1/240
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders1/240
Benign breast neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/240
Brain injuryNervous system disorders1/240
Varicose veinVascular disorders1/240
Most frequent other events
Showing 10 of 23
Most frequent other events
EventRimegepant 75 mg ODT
COVID-19Infections and infestations100/240
Upper respiratory tract infectionInfections and infestations28/240
HyperuricaemiaMetabolism and nutrition disorders18/240
NasopharyngitisInfections and infestations17/240
HyperlipidaemiaMetabolism and nutrition disorders16/240
PyrexiaGeneral disorders13/240
Weight increasedInvestigations11/240
Oropharyngeal painRespiratory, thoracic and mediastinal disorders10/240
Hepatic function abnormalHepatobiliary disorders10/240
Weight decreasedInvestigations9/240

Baseline characteristics

Full Analysis set included all participants who were enrolled and received at least one dose of the investigational product.

Age, Continuous
Age, Continuous(Years)Rimegepant 75mg ODT
Mean39.1 ± 10.97
Sex: Female, Male
Sex: Female, Male(Participants)Rimegepant 75mg ODT
Female192
Male48
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Rimegepant 75mg ODT
American Indian or Alaska Native0
Asian240
Native Hawaiian or Other Pacific Islander0
Black or African American0
White0
More than one race0
Unknown or Not Reported0
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Rimegepant 75mg ODT
Han231
Unknown or not reported9
08

Study locations

26 sites
  • The Second Hospital of Anhui Medical University
    Hefei, Anhui 230601, China
  • Beijing Friendship Hospital, Capital Medical University
    Beijing, Beijing 100050, China
  • Chinese PLA General Hospital
    Beijing, Beijing 100089, China
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, Chongqing 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 200065, China
  • West China Hospital of Sichuan University
    Chengdu, Sichuan 610000, China
  • The Second Affiliated Hospital of Xinjiang Medical University
    Wulumuqi, 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
09

References and documents

Study documents

  • Study protocol · Sep 7, 2023
  • Statistical analysis plan · Sep 10, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05371652
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
May 12, 2022
Start date
May 19, 2022
Primary completion
Feb 6, 2024
Completion
Feb 6, 2024
Results posted
Feb 20, 2025
Last update
Feb 20, 2025

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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