Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)
Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects
2 other identifiers
interventional
897
1 country
50
Brief Summary
This study is being conducted to determine the appropriate dose of rimegepant in Japanese subjects, as well as to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the acute treatment of migraine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2022
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
August 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2024
CompletedResults Posted
Study results publicly available
February 10, 2025
CompletedMarch 7, 2025
February 1, 2025
1.4 years
May 27, 2022
January 14, 2025
March 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose
Pain freedom at 2 hours post-dose was defined as having a pain intensity of none at that time point. Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. Participants with score of 0 (no pain) were considered to have freedom from pain. Formal statistical hypothesis testing was planned only for rimegepant 75 mg group with controlling type 1 error by the prespecified hierarchical gate-keeping procedure. For rimegepant 25 mg, no formal statistical hypothesis testing was conducted for any outcome measures as pre-specified in Statistical Analysis Plan (SAP).
2 hours post-dose
Secondary Outcomes (17)
Percentage of Participants With Pain Relief at 2 Hours Post-Dose
2 hours post-dose
Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-Dose
2 hours post-dose
Percentage of Participants With Ability to Function Normally at 2 Hours Post-Dose
2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-Dose
2 to 24 hours post-dose
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-Dose
Within 24 hours post-dose
- +12 more secondary outcomes
Study Arms (3)
Rimegepant 25 mg
EXPERIMENTALSingle dose of 25 mg orally disintegrating tablet of rimegepant
Rimegepant 75 mg
EXPERIMENTALSingle dose of 75 mg orally disintegrating tablet of rimegepant
Placebo
PLACEBO COMPARATORMatching placebo tablet
Interventions
Single dose of 25 mg orally disintegrating tablet of rimegepant
Single dose of 75 mg orally disintegrating tablet of rimegepant
Eligibility Criteria
You may qualify if:
- Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, including the following:
- Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age.
- Migraine attacks, on average, lasting about 4-72 hours if untreated.
- Not more than 8 attacks of moderate to severe intensity per month within the last 3 months.
- Ability to distinguish migraine attacks from tension/cluster headaches.
- Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to Screening Visit and maintains this requirement during the Screening period.
- Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to Screening Visit and maintains this requirement during the Screening Period.
- Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months prior to the Screening Visit, and if the dose is not expected to change during the course of the study.
- Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria.
You may not qualify if:
- Subject has a history of migraine with brainstem aura (basilar migraine), hemiplegic migraine or retinal migraine.
- History of use of analgesics (e.g. nonsteroidal anti-inflammatory drugs \[NSAIDs\] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit.
- Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS), Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening.
- Uncontrolled hypertension or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to screening).
- Subject with other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments.
- Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has a disease that causes malabsorption.
- The subject has a history or current evidence of any unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known or suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial.
- History of alcohol abuse and/or illicit drug use meeting DSM-V criteria for substance use disorder within 6 months of screening.
- Participation in any other investigational clinical trial while participating in this clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (50)
Tokyo Dental College Ichikawa General Hospital
Ichikawa-shi, Chiba, 272-8513, Japan
Medical Corporation Seikokai Takanoko Hospital
Matsuyama, Ehime, 790-0925, Japan
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka, 816-0802, Japan
Ikeda Neurosurgical Clinic
Kasuga-shi, Fukuoka, 816-0824, Japan
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, 373-8585, Japan
DOI CL Intern. Med./Neurol.
Hiroshima, Hiroshima, 730-0031, Japan
Japanese Red Cross Asahikawa Hospital
Asahikawa-shi, Hokkaido, 070-8530, Japan
Higashi Sapporo Neurology and Neurosurgery Clinic
Sapporo, Hokkaido, 003-0003, Japan
Nakamura Memorial Hospital
Sapporo, Hokkaido, 060-8570, Japan
Konan Medical Center
Kobe, Hyōgo, 658-0064, Japan
Nishinomiya Municipal Central Hospital
Nishinomiya-shi, Hyōgo, 663-8014, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015, Japan
Kijima Neurosurgery Clinic
Kahoku-gun, Ishikawa-ken, 929-0342, Japan
Iwate Med. Univ. Uchimaru MC
Morioka, Iwate, 020-8505, Japan
Atsuchi Neurosurgery Hospital
Kagoshima, Kagoshima-ken, 892-0842, Japan
Tanaka Neurosurgical Clinic
Kagoshima, Kagoshima-ken, 892-0844, Japan
St. Marianna Univ. Hospital
Kawasaki-shi, Kanagawa, 216-8511, Japan
Fujitsu Clinic
Nakahara, Kanagawa, 211-8588, Japan
Atago Hospital
Kochi, Kochi, 780-0051, Japan
Umenotsuji Clinic
Kochi, Kochi, 780-8011, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861- 4193, Japan
Kyoto Okamoto Memorial Hospital
Kumiyama-cho, Kyoto, 613-0034, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Ishikawa Clinic
Sakyo-ku, Kyoto, 606-0851, Japan
Tatsuoka Neurology Clinic
Shimogyo-ku, Kyoto, 600-8811, Japan
Narikawa Neurological Clinic
Izumi-ku, Miyagi, 981-3126, Japan
Sendai Headache and Neurology Clinic, Medical Corporation
Sendai, Miyagi, 982-0014, Japan
Ooba CL Neurosurg. & Headache
Ōita, Oita Prefecture, 870-0831, Japan
Makabe Clinic
Okayama, Okayama-ken, 700-0964, Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, Okayama-ken, 700-8557, Japan
Tominaga Clinic
Naniwa-ku, Osaka, 556-0015, Japan
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
Osaka, Osaka, 530-8480, Japan
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511, Japan
Takase Intern. Med. Clinic
Toyonaka-shi, Osaka, 560-0012, Japan
Saitama Medical University Hospital
Iruma-gun, Saitama, 350-0495, Japan
JRC Shizuoka Hospital
Shizuoka, Shizuoka, 420-0853, Japan
Dokkyo Medical Univ. Hosp.
Shimotsuga-gun, Tochigi, 321-0293, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431, Japan
Tokai university hachioji hospital
Hachioji-shi, Tokyo, 192-0032, Japan
Shinagawa Strings Clinic
Minato-ku, Tokyo, 108-0075, Japan
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642, Japan
USUDA CLINIC for internal medicine
Setagaya-ku, Tokyo, 156-0043, Japan
Tokyo Headache Clinic
Shibuya-Ku, Tokyo, 151-0051, Japan
Fukuuchi Pain Clinic
Shinjuku-ku, Tokyo, 160-0017, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Nishiogi Pain Clinic
Suginami-ku, Tokyo, 167-0054, Japan
Suzuki Kei Yasuragi clinic
Tachikawa, Tokyo, 190-0001, Japan
Sakura Neuro Clinic
Toyama, Toyama, 930-0803, Japan
Nagamitsu Clinic
Hofu-shi, Yamaguchi, 747-0802, Japan
Nagaseki Headache Clinic
Kai-shi, Yamanashi, 400-0124, Japan
Related Publications (1)
Ikeda K, Matsumori Y, Kudo M, Ishikawa T, Hoshino Y, Yoshimatsu H, Thiry A, Arakawa A, Croop R, Fullerton T, Sakai F, Takeshima T. Efficacy and safety of rimegepant for the acute treatment of migraine in Japan: A dose-ranging, double-blind, randomized controlled trial. Headache. 2025 Nov-Dec;65(10):1811-1820. doi: 10.1111/head.14994. Epub 2025 Jun 30.
PMID: 40586377DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 1, 2022
Study Start
August 9, 2022
Primary Completion
January 19, 2024
Study Completion
January 19, 2024
Last Updated
March 7, 2025
Results First Posted
February 10, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
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.