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New migraine prevention pill shows promise in japanese trial

NCT ID NCT05399485

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether the drug rimegepant, taken as a dissolving tablet every other day, could prevent migraines in Japanese adults. About 496 people with a history of migraines participated. The main goal was to see if rimegepant reduced the number of migraine days per month compared to a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
rimegepant (a drug taken as a dissolving tablet every other day)
What this could lead to
If successful, this could provide a new preventive option for people with migraines, reducing the number of migraine days per month.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all migraine patients. Rimegepant may cause side effects and is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

496 people

The number who actually took part.

Started

Aug 2022

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following: 1. Age of onset of migraines prior to 50 years of age. 2. Migraine attacks, on average, lasting 4 to 72 hours if untreated. 3. Per subject report, 4 to18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol). 4. 4 or more migraine days during Observation Period. 5. Not more than 18 headache days during the Observation Period. 6. Ability to distinguish migraine attacks from tension/cluster headaches. 7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Observation Period, and the dose is not expected to change during the course of the study. 8. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria. Exclusion Criteria: 1. Subject has a history of migraine with brainstem aura (basilar migraine), hemiplegic migraine or retinal migraine. 2. Subjects with headaches occurring 19 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit. 3. History of systemic 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. 4. Subject with a history of HIV disease. 5. 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. 6. Uncontrolled hypertension, or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for 3 months prior to screening). 7. Subject with other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, might interfere with study assessments. 8. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption. 9. 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. 10. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit. 11. Participation in any other investigational clinical trial while participating in this clinical trial.

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Conditions

The condition(s) this trial relates to.

Headache migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

Contacts and locations

Locations

  • Atago Hospital

    Kochi, Kochi, 780-0051, Japan

  • Atsuchi Neurosurgery Hospital

    Kagoshima, Kagoshima-ken, 892-0842, Japan

  • Doi Clinic Internal Medicine/Neurology

    Hiroshima, Hiroshima, 730-0031, Japan

  • Dokkyo Medical Univ. Hosp.

    Shimotsuga-gun, Tochigi, 321-0293, Japan

  • Fujitsu Clinic

    Nakahara, Kanagawa, 211-8588, Japan

  • Fukuuchi Pain Clinic

    Shinjuku-ku, Tokyo, 160-0017, Japan

  • Higashi Sapporo Neurology and Neurosurgery Clinic

    Sapporo, Hokkaido, 003-0003, Japan

  • Ikeda Neurosurgical Clinic

    Kasuga-shi, Fukuoka, 816-0824, Japan

  • Iwate Medical University Uchimaru Medical Center

    Morioka, Iwate, 020-8505, Japan

  • Japanese Red Cross Asahikawa Hospital

    Asahikawa-shi, Hokkaido, 070-8530, Japan

  • Japanese Red Cross Shizuoka Hospital

    Shizuoka, Shizuoka, 420-0853, Japan

  • Jinnouchi Neurosurgical Clinic

    Kasuga-shi, Fukuoka, 816-0802, Japan

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo, 113-8431, Japan

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582, Japan

  • Kijima Neurosurgery Clinic

    Kahoku-gun, Ishikawa-ken, 929-0342, Japan

  • Kindai University Hospital

    Osakasayama-shi, Osaka, 589-8511, Japan

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642, Japan

  • Konan Medical Center

    Higashinada-ku, Hyōgo, 658-0064, Japan

  • Makabe Clinic

    Okayama, Okayama-ken, 700-0964, Japan

  • Medical Corporation Seikokai Takanoko Hospital

    Matsuyama, Ehime, 790-0925, Japan

  • Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-kofukai

    Osaka, Osaka, 530-8480, Japan

  • Mito Kyodo General Hospital

    Mito, Ibaraki, 310-0015, Japan

  • Nagamitsu Clinic

    Hofu-shi, Yamaguchi, 747-0802, Japan

  • Nagaseki Headache Clinic

    Kai-shi, Yamanashi, 400-0124, Japan

  • Nakamura Memorial Hospital

    Chūōku, Hokkaido, 060-8570, Japan

  • Nishinomiya Munic. Ctr. Hosp.

    Nishinomiya-shi, Hyōgo, 663-8014, Japan

  • Nishiogi Pain Clinic

    Suginami-ku, Tokyo, 167-0054, Japan

  • Okayama City General Medical Center Okayama City Hospital

    Okayama, Okayama-ken, 700-8557, Japan

  • Ooba Clinic for Neurosurgery & Headache

    Ōita, Oita Prefecture, 870-0831, Japan

  • SUBARU Health Insurance Society Ota Memorial Hospital

    Ota-shi, Gunma, 373-8585, Japan

  • Saiseikai Kumamoto Hospital

    Kumamoto, Kumamoto, 861- 4193, Japan

  • Saitama Medical University Hospital

    Iruma-gun, Saitama, 350-0495, Japan

  • Saitama Neuropsychiatric Institute

    Saitama-shi, Saitama, 338-8577, Japan

  • Sakura Neuro Clinic

    Toyama, Toyama, 930-0803, Japan

  • Sendai Headache and Neurology Clinic, Medical Corporation

    Sendai, Miyagi, 982-0014, Japan

  • Shinagawa Strings Clinic

    Minato-ku, Tokyo, 108-0075, Japan

  • St. Marianna Univ. Hospital

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • Takase Intern. Med. Clinic

    Toyonaka-shi, Osaka, 560-0012, Japan

  • Tanaka Neurosurgical Clinic

    Kagoshima, Kagoshima-ken, 892-0844, Japan

  • Tatsuoka Neurology Clinic

    Kyoto, Kyoto, 600-8811, Japan

  • Tokai univ. hachioji hosp.

    Hachioji-shi, Tokyo, 192-0032, Japan

  • Tominaga Clinic

    Osaka, Osaka, 556-0015, Japan

  • USUDA CLINIC for internal medicine

    Setagaya-ku, Tokyo, 156-0043, Japan

  • Umenotsuji Clinic

    Kochi, Kochi, 780-8011, Japan

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