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Migraine drug eptinezumab tested for Long-Term safety in japanese patients

NCT ID NCT05064371

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study looked at the long-term safety of eptinezumab, a drug given by IV infusion to prevent migraines. It included 160 Japanese patients who had already completed a previous study. The main goal was to see if the drug is safe and tolerable over 60 weeks of treatment.

What this could mean

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

Active substance
eptinezumab
What this could lead to
If successful, this could confirm that eptinezumab is safe for long-term use to prevent migraines, offering a reliable treatment option.
What could go wrong
This is an extension study focused on safety, not on proving how well it works. It is also limited to Japanese participants, so results may not apply to everyone.

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

160 people

The number who actually took part.

Started

Sep 2021

Finished

Jun 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 to 75 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.

Key Inclusion Criteria: * The participant has completed the Primary Outcome Visit (Visit 5) of the lead-in Study 19140A immediately prior to enrolment into this study. * The participant is indicated for 60-week preventive treatment of chronic migraine with eptinezumab according to the clinical opinion of the investigator. Key Exclusion Criteria: * The participant has a serious adverse event (SAE) or a moderate or severe ongoing AE from the Lead-In study considered a potential safety risk by the investigator. * The participant has a clinically relevant change in vital signs or electrocardiogram (ECG) from the Lead-In study considered a potential safety risk by the investigator. * The participant has a disease or takes medication that could, in the investigator's opinion, interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study. Other inclusion and exclusion criteria may apply.

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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

  • Atsuchi Neurosurgery Hospital

    Kagoshima, Kagoshima-ken, 892-0842, Japan

  • DOI Clinic Internal Medicine

    Hiroshima-Shi Naka-Ku, Hiroshima, 730-0031, Japan

  • Dokkyo Medical University Hospital

    Mibu-machi, 321-0293, Japan

  • Ikeda Neurosurgical Clinic

    Kasuga-Shi, Hukuoka, 816-0824, Japan

  • Iwate Medical University Uchimaru Medical Center

    Morioka, Iwate, 020-0023, Japan

  • Japanese Red Cross Shizuoka Hospital

    Shizuoka, 420-0853, Japan

  • Jinnouchi Neurosurgery Clinic

    Kasuga-Shi, Hukuoka, 816-0802, Japan

  • Mito Kyodo General Hospital

    Mito, Ibaraki, 310-0015, Japan

  • Moriyama Neurological Center Hospital

    Edogawa-Ku, Tokyo, 134-0085, Japan

  • Nagamitsu Clinic

    Hofu-Shi, Yamaguchi, 747-0802, Japan

  • Saitama Neuropsychiatric Institute

    Saitama-Shi, Saitama, 338-8577, Japan

  • Sendai Headache and Cranial Nerves Clinic

    Sendai-Shi Taihaku-Ku, Miyagi, 982-0014, Japan

  • Shin Matsudakai Atago Hospital

    Kochi, Kôti, 780-0051, Japan

  • Tatsuoka Neurology Clinic

    Kyoto Shimojo-ku, 680-8811, Japan

  • Tokyo headache clinic

    Shibuya-Ku, Tokyo, 151-0051, Japan

  • Tominaga Hospital

    Osaka, Ã"saka, 556-0017, Japan

  • Toyota Memorial Hospital

    Toyota-shi, 471-8513, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.