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New migraine prevention pill shows promise in japan trial

NCT ID NCT05861427

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a daily oral medication called atogepant (brand name Qulipta) can prevent migraines in Japanese adults who have 4 to 14 migraine days per month. Over 500 participants were randomly assigned to receive one of three doses of atogepant or a placebo for 12 weeks, followed by an extension where all received atogepant. The main goal was to see if atogepant reduces the number of monthly migraine days compared to placebo.

What this could mean

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

Active substance
atogepant (Qulipta)
What this could lead to
If successful, this could provide a new daily pill option for Japanese adults to reduce the number of migraine days per month.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. Atogepant is already approved in the US, but its effectiveness and safety in Japanese patients may differ.

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

524 people

The number who actually took part.

Started

Jul 2023

Finished

Mar 2025

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 to 80 years

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: * At least a 1-year history of migraine (with or without aura). * Less than 50 years of age at the time of migraine onset. * History of 4 to 14 migraine days per month in the 3 months prior to screening. * 4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline period per the eDiary. Exclusion Criteria: * Difficulty with distinguishing migraine headaches from tension-type or other headaches. * Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Atago Hospital /ID# 245818

    Kochi, Kochi, 780-0051, Japan

  • Chibune General Hospital /ID# 245973

    Osaka, Osaka, 555-0034, Japan

  • DOI Internal Medicine-Neurology Clinic /ID# 245661

    Hiroshima, 730-0031, Japan

  • Dokkyo Medical University Hospital /ID# 246472

    Mibu, Tochigi, 321-0293, Japan

  • Fujitsu Clinic /ID# 245811

    Kawasaki-shi, Kanagawa, 211-8588, Japan

  • Fukuiken Saiseikai Hospital /ID# 245662

    Fukui-shi, Fukui, 918-8503, Japan

  • Gokeikai Osaka Kaisei Hospital /ID# 246623

    Osaka, Osaka, 532-0003, Japan

  • Higashi Sapporo Neurology And Neurosurgery Clinic /ID# 245667

    Sapporo, Hokkaido, 003-0003, Japan

  • Hiroshima City Hiroshima Citizens Hospital /ID# 246683

    Hiroshima, Hiroshima, 730-8518, Japan

  • Ikeda Neurosurgical Clinic /ID# 245881

    Kasuga-shi, Fukuoka, 816-0824, Japan

  • Japanese Red Cross Shizuoka Hospital /ID# 246204

    Shizuoka, Shizuoka, 420-0853, Japan

  • Jinnouchi Neurosurgical Clinic /ID# 245510

    Kasuga-shi, Fukuoka, 816-0802, Japan

  • Kanazawa Neurosurgical Hospital /ID# 254210

    Nonoichi-shi, Ishikawa-ken, 921-8841, Japan

  • Keio University Hospital /ID# 245660

    Shinjuku-ku, Tokyo, 160-8582, Japan

  • Kijima Neurosurgery Clinic /ID# 245758

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

  • Kitasato University Kitasato Institute Hospital /ID# 246470

    Minato-ku, Tokyo, 108-8642, Japan

  • Kokubu Clinic /ID# 245810

    Takamatsu, Kagawa-ken, 769-0103, Japan

  • Konan Medical Center /ID# 245557

    Kobe, Hyōgo, 658-0064, Japan

  • Makabe Clinic /ID# 246621

    Okayama, Okayama-ken, 700-0964, Japan

  • Mito Kyodo General Hospital /ID# 245487

    Mito, Ibaraki, 310-0015, Japan

  • Nagaseki Headache Clinic /ID# 245485

    Kai, Yamanashi, 400-0124, Japan

  • Nakamura Memorial Hospital /ID# 247379

    Sapporo, Hokkaido, 060-8570, Japan

  • Narikawa Neurological Clinic /ID# 254023

    Sendai, Miyagi, 981-3126, Japan

  • Nishinomiya Municipal Central Hospital /ID# 246571

    Nishinomiya-shi, Hyōgo, 663-8014, Japan

  • Okayama City General Medical Center /ID# 246007

    Okayama, Okayama-ken, 700-8557, Japan

  • Ooba Clinic for Neurosurgery & Headache /ID# 246201

    Ōita, Oita Prefecture, 8700831, Japan

  • SUBARU Health Insurance Society Ota Memorial Hospital /ID# 247948

    Ota-shi, Gunma, 373-8585, Japan

  • Saino Clinic /ID# 245921

    Tokorozawa-shi, Saitama, 359-1141, Japan

  • Saiseikai Kumamoto Hospital /Id# 253546

    Kumamoto, Kumamoto, 861-4101, Japan

  • Saitama Medical University Hospital /ID# 245663

    Iruma-gun, Saitama, 350-0495, Japan

  • Sakura neuro Clinic /ID# 248320

    Toyama, Toyama, 930-0803, Japan

  • Sendai Headache and Neurology Clinic Medical Corporation /ID# 245664

    Sendai, Miyagi, 982-0014, Japan

  • Shinagawa Strings Clinic /ID# 245665

    Tokyo, 108-0075, Japan

  • Suzuki Kei Yasuragi Clinic /ID# 253493

    Tachikawa-shi, Tokyo, 190-0001, Japan

  • Takanoko Hospital /ID# 245658

    Matsuyama, Ehime, 790-0925, Japan

  • Takase Internal Medicine Clinic /ID# 245532

    Toyonaka-shi, Osaka, 560-0012, Japan

  • Tanaka Neurosurgery & Headache Clinic /ID# 245488

    Kagoshima, 890-0052, Japan

  • Tatsuoka Neurology Clinic /ID# 245328

    Kyoto, 600-8811, Japan

  • Tendo Brain Clinic /ID# 246205

    Tendo-shi, Yamagata, 994-0083, Japan

  • Tokai University Hachioji Hospital /ID# 248326

    Hachioji-shi, Tokyo, 192-0032, Japan

  • Tokai University Hospital /ID# 245971

    Isehara, Kanagawa, 259-1193, Japan

  • Tokyo Dental College Ichikawa General Hospital /ID# 247436

    Ichikawa-shi, Chiba, 272-0824, Japan

  • Tokyo Headache Clinic /ID# 245486

    Shibuya-ku, Tokyo, 151-0051, Japan

  • Tominaga Clinic /ID# 245812

    Osaka, Osaka, 5560015, Japan

  • Tsukuba Neurosurgery/Headache Clinic /ID# 254665

    Tsukuba, Ibaraki, 305-0822, Japan

  • Umenotsuji Clinic /ID# 246103

    Kochi, Kochi, 780-8011, Japan

  • Usuda Clinic Of Internal Medicine /ID# 246166

    Setagaya-ku, Tokyo, 156-0043, Japan

  • Yamaguchi Clinic /ID# 246370

    Nishinomiya-shi, Hyōgo, 663-8204, Japan

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