MigrainePhase 3NCT05399459
Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)
A Phase 3 study testing Rimegepant 25 MG and Rimegepant 75 MG in people with Migraine, run by Pfizer at 50 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- Rimegepant 25 MG and Rimegepant 75 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 897 participants
- Where
- 50 sitesJapan
- Study dates
- 9 Aug 2022to 19 Jan 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
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
Japan50 sites
Japanese Red Cross Asahikawa Hospital
Asahikawa-shi, Hokkaido, 070-8530
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Tokai university hachioji hospital
Hachioji-shi, Tokyo, 192-0032
DOI CL Intern. Med./Neurol.
Hiroshima, Hiroshima, 730-0031
Nagamitsu Clinic
Hofu-shi, Yamaguchi, 747-0802
Tokyo Dental College Ichikawa General Hospital
Ichikawa-shi, Chiba, 272-8513
Saitama Medical University Hospital
Iruma-gun, Saitama, 350-0495
Narikawa Neurological Clinic
Izumi-ku, Miyagi, 981-3126
Atsuchi Neurosurgery Hospital
Kagoshima, Kagoshima-ken, 892-0842
Tanaka Neurosurgical Clinic
Kagoshima, Kagoshima-ken, 892-0844
Kijima Neurosurgery Clinic
Kahoku-gun, Ishikawa-ken, 929-0342
Nagaseki Headache Clinic
Kai-shi, Yamanashi, 400-0124
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka, 816-0802
Ikeda Neurosurgical Clinic
Kasuga-shi, Fukuoka, 816-0824
St. Marianna Univ. Hospital
Kawasaki-shi, Kanagawa, 216-8511
Konan Medical Center
Kobe, Hyōgo, 658-0064
Atago Hospital
Kochi, Kochi, 780-0051
Umenotsuji Clinic
Kochi, Kochi, 780-8011
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861- 4193
Kyoto Okamoto Memorial Hospital
Kumiyama-cho, Kyoto, 613-0034
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
Medical Corporation Seikokai Takanoko Hospital
Matsuyama, Ehime, 790-0925
Shinagawa Strings Clinic
Minato-ku, Tokyo, 108-0075
Kitasato University Kitasato Institute Hospital
Minato-ku, Tokyo, 108-8642
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015
Iwate Med. Univ. Uchimaru MC
Morioka, Iwate, 020-8505
Fujitsu Clinic
Nakahara, Kanagawa, 211-8588
Tominaga Clinic
Naniwa-ku, Osaka, 556-0015
Nishinomiya Municipal Central Hospital
Nishinomiya-shi, Hyōgo, 663-8014
Ooba CL Neurosurg. & Headache
Ōita, Oita Prefecture, 870-0831
Makabe Clinic
Okayama, Okayama-ken, 700-0964
Okayama City General Medical Center Okayama City Hospital
Okayama, Okayama-ken, 700-8557
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai
Osaka, Osaka, 530-8480
Kindai University Hospital
Osakasayama-shi, Osaka, 589-8511
SUBARU Health Insurance Society Ota Memorial Hospital
Ota-shi, Gunma, 373-8585
Ishikawa Clinic
Sakyo-ku, Kyoto, 606-0851
Higashi Sapporo Neurology and Neurosurgery Clinic
Sapporo, Hokkaido, 003-0003
Nakamura Memorial Hospital
Sapporo, Hokkaido, 060-8570
Sendai Headache and Neurology Clinic, Medical Corporation
Sendai, Miyagi, 982-0014
USUDA CLINIC for internal medicine
Setagaya-ku, Tokyo, 156-0043
Tokyo Headache Clinic
Shibuya-Ku, Tokyo, 151-0051
Tatsuoka Neurology Clinic
Shimogyo-ku, Kyoto, 600-8811
Dokkyo Medical Univ. Hosp.
Shimotsuga-gun, Tochigi, 321-0293
Fukuuchi Pain Clinic
Shinjuku-ku, Tokyo, 160-0017
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
JRC Shizuoka Hospital
Shizuoka, Shizuoka, 420-0853
Nishiogi Pain Clinic
Suginami-ku, Tokyo, 167-0054
Suzuki Kei Yasuragi clinic
Tachikawa, Tokyo, 190-0001
Sakura Neuro Clinic
Toyama, Toyama, 930-0803
Takase Intern. Med. Clinic
Toyonaka-shi, Osaka, 560-0012
About this study
Official title: 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
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.
- Conditions
- Migraine
- Being tested
- Rimegepant 25 MG, Rimegepant 75 MG, Placebo
- Keywords
- Migraine, Headache, Acute Migraine
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant 25 MGDrug
Also called BHV3000
Single dose of 25 mg orally disintegrating tablet of rimegepant
Rimegepant 75 MGDrug
Also called BHV3000
Single dose of 75 mg orally disintegrating tablet of rimegepant
PlaceboDrug
Matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Rimegepant 25 mg | Experimental | Single dose of 25 mg orally disintegrating tablet of rimegepant Receives: Drug: Rimegepant 25 MG |
| Rimegepant 75 mg | Experimental | Single dose of 75 mg orally disintegrating tablet of rimegepant Receives: Drug: Rimegepant 75 MG |
| Placebo | Placebo comparator | Matching placebo tablet Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 hours post-dose
Secondary outcomes (17)
Percentage of Participants With Pain Relief at 2 Hours Post-Dose
Pain relief at 2 hours post-dose was defined as a pain intensity of none or mild at that time point. Pain was measured on a 4-point Likert scale, with following scores: 0= none, 1= mild, 2= moderate, 3= severe. 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 SAP.
Measured: 2 hours post-dose
Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-Dose
MBS freedom was defined as MBS reported before dosing that was absent post-dose. MBS included nausea, photophobia, or phonophobia. MBS were measured using a binary scale as 0= absent, 1= present. Participants who had score of 0 (MBS absent) were considered to have freedom from MBS. 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 SAP.
Measured: 2 hours post-dose
Percentage of Participants With Ability to Function Normally at 2 Hours Post-Dose
Functional disability was defined as a functional disability level of mildly impaired, severely impaired, or required bedrest. Participants rated the level of disability they perceived as a result of their migraine in performing normal actions using following level of severity: normal function, mild impairment, severe impairment, or required bedrest. Percentage of participants with a response of "normal function" at the 2 hours post-dose were reported in this outcome measure. 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 SAP.
Measured: 2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-Dose
Sustained Pain relief from 2 to 24 hours post-dose was defined as a pain intensity of none or mild at all time points from 2 to 24 hours post-dose. 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 (with no pain) through 2 to 24 hours post-dose were considered to have sustained pain relief. 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 SAP.
Measured: 2 to 24 hours post-dose
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-Dose
Percentage of participants who used rescue medications within 24 hours of administration of study drug were reported in this outcome measure. 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 SAP.
Measured: Within 24 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-Dose
Sustained pain relief from 2 to 48 hours post-dose was defined as a pain intensity of none or mild at all time points from 2 to 48 hours post-dose. 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 (with no pain) through 2 to 48 hours post-dose were considered to have sustained pain relief. 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 SAP.
Measured: 2 to 48 hours post-dose
Percentage of Participants With Absence of Photophobia at 2 Hours Post-Dose
Photophobia (sensitivity to light) status was measured as absent or present in the electronic diary (eDiary). Freedom from photophobia was defined as photophobia absent. 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 SAP.
Measured: 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-Dose
Sustained pain freedom from 2 to 24 hours post-dose was defined as a pain intensity of none at all time points from 2 to 24 hours post-dose. 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 (with no pain) through 2 to 24 hours post-dose were considered to have sustained pain freedom. 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 SAP.
Measured: 2 to 24 hours post-dose
Percentage of Participants With Freedom of Phonophobia at 2 Hours Post-Dose
Phonophobia (sensitivity to sound) status was measured as absent or present in the eDiary. Freedom from phonophobia was defined as phonophobia absent. 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 SAP.
Measured: 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-Dose
Sustained pain freedom from 2 to 48 hours post-dose was defined as a pain intensity of none at all time points from 2 to 48 hours post-dose. 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 (with no pain) through 2 to 48 hours post-dose were considered to have sustained pain freedom. 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 SAP.
Measured: 2 to 48 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post Dose
Nausea status was measured as absent or present in the eDiary. Freedom from nausea was defined as nausea absent. 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 SAP.
Measured: 2 hours post-dose
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-Dose
Pain relapse from 2 to 48 hours post-dose was defined as pain intensity of mild, moderate, or severe at any time point post-dose after 2 hours post-dose for the subset of participants with pain intensity of none at 2 hours post-dose. Pain levels were assessed on a 4-point scale (none, mild, moderate, severe) using the eDiary. 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 SAP.
Measured: 2 to 48 hours post-dose
Number of Participants With Adverse Events (AEs) by Intensity
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participants or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with the treatment. AE intensity included mild, moderate and severe. Mild AE is defined as AEs which is usually transient and may require only minimal treatment or therapeutic intervention. The event were not generally interfered with usual activities of daily living. Moderate AE is defined as AEs which is usually alleviated with additional specific therapeutic intervention. The event interfered with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the participants. Severe AE is defined as AE that interrupts with usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.
Measured: From the day of signing informed consent up to end of treatment visit (approximately maximum up to 11 weeks)
Number of Participants With Serious AEs
A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/ incapacity; resulted in congenital anomaly/birth defect in the off spring who received rimegepant were considered an important medical event.
Measured: From the day of signing informed consent up to end of treatment visit (approximately maximum up to 11 weeks)
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Hematology
Laboratory test abnormalities in hematology included: Eosinophils, Hemoglobin (high, low), Lymphocytes (high, low), Neutrophils, Platelets, White blood cell count (high, low). Laboratory abnormality events were graded according to National Cancer Institute Common Terminology Criteria For Adverse Events (NCI CTCAE) v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. Number of participants who had hematology parameter abnormality Grade 3 to 4 are reported in this outcome measure. Number of participants with non-zero laboratory abnormalities were reported in this outcome measure.
Measured: Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks]
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Serum Chemistry
Laboratory test abnormalities in serum chemistry included: alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bicarbonate, Bilirubin (total), calcium (high, low), cholesterol (total), creatine kinase, creatinine, estimated glomerular filtration rate (eGFR), Modification of Diet in Renal Disease (MDRD), glucose, (high, low), lactate dehydrogenase low density lipoprotein (LDL) cholesterol (fasting, non-fasting), potassium (high, low), sodium (high, low), triglycerides (fasting, non-fasting), uric acid. Laboratory abnormality events were graded according to NCI CTCAE v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. Number of participants who had serum chemistry parameter abnormality Grade 3 to 4 are reported in this outcome measure. Number of participants with non-zero laboratory abnormalities are reported in this outcome measure.
Measured: Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks]
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Urinalysis
Laboratory test abnormalities in urinalysis included: Urine glucose, Urine protein, pH, specific gravity, ketones, nitrites, urobilinogen, leukocyte esterase, blood. If blood, protein or leukocytes are positive and determined clinically significant by the investigator, then the participants were returned for an unscheduled visit for microscopic examination. Laboratory abnormality events were graded according to NCI CTCAE v5.0; grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threatening consequences and grade 5=death. Number of participants who had urinalysis parameter abnormality Grade 3 to 4 are reported in this outcome measure. Number of participants with non-zero laboratory abnormalities are reported in this outcome measure.
Measured: Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start9 Aug 2022
- Primary completion19 Jan 2024
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 897 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399459
- Sponsor's protocol ID
- BHV3000-313
- Other IDs
- C4951022
- Status last verified
- Feb 2025
- First submitted
- 27 May 2022
- Last updated
- 7 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- 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
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.
PubMed 40586377
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05399459
- Acronym / sponsor ID
- BHV3000-313
- Conditions
- Migraine
- Keywords
- Migraine, Headache, Acute Migraine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 897 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 19 Jan 2024 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rimegepant 25 mg | Experimental | Drug: Rimegepant 25 MGSingle dose of 25 mg orally disintegrating tablet of rimegepant |
| Rimegepant 75 mg | Experimental | Drug: Rimegepant 75 MGSingle dose of 75 mg orally disintegrating tablet of rimegepant |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rimegepant 25 MGAlso: BHV3000Single dose of 25 mg orally disintegrating tablet of rimegepant | Drug | Rimegepant 25 mg |
| Rimegepant 75 MGAlso: BHV3000Single dose of 75 mg orally disintegrating tablet of rimegepant | Drug | Rimegepant 75 mg |
| PlaceboMatching placebo tablet | Drug | Placebo |
Primary outcome
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose
Time frame: 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).
17 secondary outcomes
Percentage of Participants With Pain Relief at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participants Who Had Freedom From Most Bothersome Symptom (MBS) at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participants With Ability to Function Normally at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 24 Hours Post-Dose
Time frame: 2 to 24 hours post-dose
Percentage of Participants Who Used Rescue Medication Within 24 Hours Post-Dose
Time frame: Within 24 hours post-dose
Percentage of Participants With Sustained Pain Relief From 2 to 48 Hours Post-Dose
Time frame: 2 to 48 hours post-dose
Percentage of Participants With Absence of Photophobia at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 24 Hours Post-Dose
Time frame: 2 to 24 hours post-dose
Percentage of Participants With Freedom of Phonophobia at 2 Hours Post-Dose
Time frame: 2 hours post-dose
Percentage of Participants With Sustained Pain Freedom From 2 to 48 Hours Post-Dose
Time frame: 2 to 48 hours post-dose
Percentage of Participants With Freedom From Nausea at 2 Hours Post Dose
Time frame: 2 hours post-dose
Percentage of Participants With Pain Relapse From 2 to 48 Hours Post-Dose
Time frame: 2 to 48 hours post-dose
Number of Participants With Adverse Events (AEs) by Intensity
Time frame: From the day of signing informed consent up to end of treatment visit (approximately maximum up to 11 weeks)
Number of Participants With Serious AEs
Time frame: From the day of signing informed consent up to end of treatment visit (approximately maximum up to 11 weeks)
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Hematology
Time frame: Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks]
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Serum Chemistry
Time frame: Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks]
Number of Participants With Grade 3 to 4 Laboratory Test Abnormalities- Urinalysis
Time frame: Baseline (Day 1) up to End of treatment visit (within 7 days of treatment) [approximately maximum up to 7 weeks]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40586377Ikeda 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rimegepant 25 MG and Rimegepant 75 MG in people with Migraine, run by Pfizer at 50 sites in Japan.
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 9 inclusion and 9 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 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Japan. 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. Some participants in this study may receive a placebo. 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 10 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?
Percentage of Participants Who Had Freedom From Pain at 2 Hours Post-Dose (time frame: 2 hours post-dose). 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 NCT05399459, 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 7 Mar 2025.