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

NCT05371652 | Completed Phase 3 Results

• 2 other identifiers: BHV3000-318C4951018
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 26

Brief Summary

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

Conditions

Acute Migraine

Keywords

Migraine

Outcome Measures

Primary Outcomes (14)

• 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.

  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

Secondary Outcomes (1)

• Change From Observation Period in the Number of Migraine Days by Pain Intensity at Every 4 Week Interval and Overall 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)

Study Arms (1)

Rimegepant 75mg Orally Disintegrating Tablets (ODT)

EXPERIMENTAL

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

Drug: Rimegepant 75mg Orally Disintegrating Tablets (ODT)

Interventions

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

Rimegepant 75mg Orally Disintegrating Tablets (ODT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit
• 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.

You may not qualify if:

• \* 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
• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (26)

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100089, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

The First Affiliated hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

Hebei General Hospital

Shijiazhuang, Hebei, 050051, China

Location

Renmin Hospital Of Wuhan University

Wuhan, Hubei, 430060, China

Location

Wuhan Third Hospital

Wuhan, Hubei, 430074, China

Location

Changsha Central Hospital

Changsha, Hunan, 410000, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410000, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130041, China

Location

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110801, China

Location

Shaanxi Provincial People' Hospital

Xi'an, Shaanxi, 710068, China

Location

The First Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi, 710082, China

Location

Yan'an University Xianyang Hospital Co., Ltd

Xianyang, Shaanxi, 712000, China

Location

LiaoCheng People's Hospital

Liaocheng, Shandong, 252000, China

Location

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 200065, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610000, China

Location

The Second Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 8320000, China

Location

The Second Affiliated hospital of Kunming Medical University

Kunming, Yunnan, 650000, China

Location

Peking University People's Hospital

Beijing, 100044, China

Location

Guangzhou First People's Hospital

Guangzhou, 510180, China

Location

Related Publications (1)

• 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.

  PMID: 41066271 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Migraine Disorders

Interventions

rimegepant sulfate

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: May 12, 2022
• Study Start: May 19, 2022
• Primary Completion: February 6, 2024
• Study Completion: February 6, 2024
• Last Updated: February 20, 2025
• Results First Posted: February 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (26)