NCT05371652

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

Completed Phase 3 Results posted Last updated 20 February 2025

What this trial tests

Phase 3 trial testing Rimegepant 75mg Orally Disintegrating Tablets (ODT) in Acute Migraine in 241 participants. Completed in 6 February 2024.

Timeline

19 May 2022

Primary endpoint
6 February 2024

6 February 2024

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	241
Start date	19 May 2022
Primary completion	6 February 2024
Estimated completion	6 February 2024
Sites	26 locations across China

Drugs / interventions tested

• Rimegepant 75mg Orally Disintegrating Tablets (ODT) (rimegepant-75mg-orally-disintegrating-tablets-odt) — full drug profile →

Conditions studied

• Acute Migraine — all drugs for Acute Migraine →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Acute Migraine. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Treatment Safety Period: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Primary · From Day 1 of study treatment up to Week 52 of the treatment safety period

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.

Group	Value	95% CI
Rimegepant 75 mg ODT	203

Follow-up Safety Period: Number of Participants With TEAEs Primary · From Week 52 to Week 54 of the follow-up safety period

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.

Group	Value	95% CI
Rimegepant 75 mg ODT	24

Treatment Safety Period: Number of Participants With Serious Adverse Events (SAEs) Primary · From Day 1 of study treatment up to Week 52 of the treatment safety period

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 anom

Group	Value	95% CI
Rimegepant 75 mg ODT	7

Follow-up Safety Period: Number of Participants With SAEs Primary · From Week 52 to Week 54 of the follow-up safety period

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 anom

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Treatment Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation Primary · From Day 1 of study treatment up to Week 52 of the treatment safety period

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.

Group	Value	95% CI
Rimegepant 75 mg ODT	1

Follow-up Safety Period: Number of Participants With AEs Leading to Study Drug Discontinuation Primary · From Week 52 to Week 54 of the follow-up safety period

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.

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Treatment Safety Period: Number of Participants With Electrocardiogram (ECG) Abnormalities Primary · From Day 1 of study treatment up to Week 52 of the treatment safety period

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.

<=450

Group	Value	95% CI
Rimegepant 75 mg ODT	225

450 - <= 480

Group	Value	95% CI
Rimegepant 75 mg ODT	6

480 - <= 500

Group	Value	95% CI
Rimegepant 75 mg ODT	0

> 500

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Follow-up Safety Period: Number of Participants With ECG Abnormalities Primary · From Week 52 to Week 54 of the follow-up safety period

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

<=450

Group	Value	95% CI
Rimegepant 75 mg ODT	209

450 - <= 480

Group	Value	95% CI
Rimegepant 75 mg ODT	2

480 - <= 500

Group	Value	95% CI
Rimegepant 75 mg ODT	0

>500

Group	Value	95% CI
Rimegepant 75 mg ODT	2

Treatment Safety Period: Number of Participants With Vital Signs Abnormalities Primary · From Day 1 of study treatment up to Week 52 of the treatment safety period

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.

Systolic BP <90

Group	Value	95% CI
Rimegepant 75 mg ODT	12

Systolic BP >140

Group	Value	95% CI
Rimegepant 75 mg ODT	9

Diastolic BP <50

Group	Value	95% CI
Rimegepant 75 mg ODT	1

Diastolic BP >90

Group	Value	95% CI
Rimegepant 75 mg ODT	17

Pulse rate <40

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Pulse rate >120

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Follow-up Safety Period: Number of Participants With Vital Signs Abnormalities. Primary · From Week 52 to Week 54 of the follow-up safety period

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.

Systolic BP <90

Group	Value	95% CI
Rimegepant 75 mg ODT	1

Systolic BP >140

Group	Value	95% CI
Rimegepant 75 mg ODT	1

Diastolic BP <50

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Diastolic BP >90

Group	Value	95% CI
Rimegepant 75 mg ODT	5

Pulse rate <40

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Pulse rate >120

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Treatment Safety Period: Number of Participants With Hematology Test Abnormalities Primary · From Day 1 of study treatment up to Week 52 of the treatment safety period

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: sev

Hemoglobin increased

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Anemia

Group	Value	95% CI
Rimegepant 75 mg ODT	1

Leukocytosis

Group	Value	95% CI
Rimegepant 75 mg ODT	0

White blood cell decreased

Group	Value	95% CI
Rimegepant 75 mg ODT	1

Platelet count decreased

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Neutrophil count decreased

Group	Value	95% CI
Rimegepant 75 mg ODT	1

Lymphocyte count increased

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Lymphocyte count decreased

Group	Value	95% CI
Rimegepant 75 mg ODT	1

Follow-up Safety Period: Number of Participants With Hematology Test Abnormalities Primary · From Week 52 to Week 54 of the follow-up safety period

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 i

Hemoglobin increased

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Anemia

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Leukocytosis

Group	Value	95% CI
Rimegepant 75 mg ODT	0

White blood cell decreased

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Platelet count decreased

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Neutrophil count decreased

Group	Value	95% CI
Rimegepant 75 mg ODT	1

Lymphocyte count increased

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Lymphocyte count decreased

Group	Value	95% CI
Rimegepant 75 mg ODT	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From Day 1 of study treatment up to Week 54. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rimegepant 75 mg ODT

Serious: 7/240 (3%)

Deaths: 1/240

Serious adverse events (7 terms)

Reaction	System	Rimegepant 75 mg ODT
Arteriosclerosis coronary artery	Cardiac disorders	—
Pneumonia	Infections and infestations	—
Clavicle fracture	Injury, poisoning and procedural complications	—
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	—
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Brain injury	Nervous system disorders	—
Varicose vein	Vascular disorders	—

Other adverse events (23 terms — click to expand)

Reaction	System	Rimegepant 75 mg ODT
COVID-19	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Hyperuricaemia	Metabolism and nutrition disorders	—
Nasopharyngitis	Infections and infestations	—
Hyperlipidaemia	Metabolism and nutrition disorders	—
Pyrexia	General disorders	—
Weight increased	Investigations	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—
Hepatic function abnormal	Hepatobiliary disorders	—
Weight decreased	Investigations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Sinus arrhythmia	Cardiac disorders	—
Anaemia	Blood and lymphatic system disorders	—
Toothache	Gastrointestinal disorders	—
Urinary tract infection	Infections and infestations	—
Alanine aminotransferase increased	Investigations	—
Influenza	Infections and infestations	—
Pharyngitis	Infections and infestations	—
Respiratory tract infection	Infections and infestations	—
Aspartate aminotransferase increased	Investigations	—
Sinus bradycardia	Cardiac disorders	—
Insomnia	Psychiatric disorders	—
Blood creatine phosphokinase increased	Investigations	—

Most-reported serious reactions: Arteriosclerosis coronary artery, Pneumonia, Clavicle fracture, Intervertebral disc protrusion, Benign breast neoplasm, Brain injury, Varicose vein.

Data from ClinicalTrials.gov NCT05371652 adverse events section.

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Rimegepant orally disintegrating tablet 75 mg for acute treatment of migraine in adults from China: a subgroup analysis of a double-blind, randomized, placebo-controlled, phase 3 clinical trial.
   Yu S, Guo A, Wang Z, Liu J, et al · · 2024 · cited 6× · PMID 38627638 · DOI 10.1186/s10194-024-01731-4
2. Rimegepant for the acute treatment of migraine: A phase 3, multicenter, open-label, long-term safety and effectiveness study in adults from China.
   Zhang M, Guo A, Wu J, Wang H, et al · · 2025 · cited 2× · PMID 41066271 · DOI 10.1177/03331024251371686
3. Abstracts from the 18 th European Headache Congress (EHC) : Rotterdam, The Netherlands. 4-7 December 2024.
   · 2025 · cited 1× · PMID 40545525 · DOI 10.1186/s10194-025-02062-8
4. Abstracts from the 17th European Headache Congress (EHC)
   · 2024