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Acute MigrainePhase 3NCT05371652

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

A Phase 3 study testing Rimegepant 75mg Orally Disintegrating Tablets (ODT) in people with Acute Migraine, run by Pfizer at 26 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Migraine
What is being tested?
Rimegepant 75mg Orally Disintegrating Tablets (ODT)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
26 sitesChina
Study dates
19 May 2022to 6 Feb 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

China26 sites

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100089

  • Peking University People's Hospital

    Beijing, 100044

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130041

  • Changsha Central Hospital

    Changsha, Hunan, 410000

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410000

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610000

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400016

  • Guangzhou First People's Hospital

    Guangzhou, 510180

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • The Second Affiliated hospital of Kunming Medical University

    Kunming, Yunnan, 650000

  • LiaoCheng People's Hospital

    Liaocheng, Shandong, 252000

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200065

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning, 110801

  • Hebei General Hospital

    Shijiazhuang, Hebei, 050051

  • The Second Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 8320000

  • Renmin Hospital Of Wuhan University

    Wuhan, Hubei, 430060

  • Wuhan Third Hospital

    Wuhan, Hubei, 430074

  • Shaanxi Provincial People' Hospital

    Xi'an, Shaanxi, 710068

  • The First Affiliated Hospital of Xi'an Medical University

    Xi'an, Shaanxi, 710082

  • The First Affiliated hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Yan'an University Xianyang Hospital Co., Ltd

    Xianyang, Shaanxi, 712000

Other trials in China

About this study

Official title: A Multicenter, Open Label, Long-term Safety Study of BHV3000 for the Acute Treatment of Migraine in Chinese Subjects

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

Conditions
Acute Migraine
Being tested
Rimegepant 75mg Orally Disintegrating Tablets (ODT)
Keywords
Migraine
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT05371652
Study groupRoleWhat they receive
Rimegepant 75mg Orally Disintegrating Tablets (ODT)ExperimentalOne rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day)
Receives: Drug: Rimegepant 75mg Orally Disintegrating Tablets (ODT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Secondary outcomes (1)

  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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2022
  2. Study start19 May 2022
  3. Primary completion6 Feb 2024
  4. Study completion6 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05371652
Sponsor's protocol ID
BHV3000-318
Other IDs
C4951018
Status last verified
Jan 2025
First submitted
23 Mar 2022
Last updated
20 Feb 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 41066271

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rimegepant 75mg Orally Disintegrating Tablets (ODT) in people with Acute Migraine, run by Pfizer at 26 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From Day 1 of study treatment up to Week 52 of the treatment safety period). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05371652, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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