Migraine drug eptinezumab tested for Long-Term safety in japanese patients
NCT ID NCT05064371
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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160 people
The number who actually took part.
- Started
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Sep 2021
- Finished
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Atsuchi Neurosurgery Hospital
Kagoshima, Kagoshima-ken, 892-0842, Japan
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DOI Clinic Internal Medicine
Hiroshima-Shi Naka-Ku, Hiroshima, 730-0031, Japan
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Dokkyo Medical University Hospital
Mibu-machi, 321-0293, Japan
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Ikeda Neurosurgical Clinic
Kasuga-Shi, Hukuoka, 816-0824, Japan
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Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, 020-0023, Japan
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Japanese Red Cross Shizuoka Hospital
Shizuoka, 420-0853, Japan
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Jinnouchi Neurosurgery Clinic
Kasuga-Shi, Hukuoka, 816-0802, Japan
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Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015, Japan
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Moriyama Neurological Center Hospital
Edogawa-Ku, Tokyo, 134-0085, Japan
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Nagamitsu Clinic
Hofu-Shi, Yamaguchi, 747-0802, Japan
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Saitama Neuropsychiatric Institute
Saitama-Shi, Saitama, 338-8577, Japan
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Sendai Headache and Cranial Nerves Clinic
Sendai-Shi Taihaku-Ku, Miyagi, 982-0014, Japan
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Shin Matsudakai Atago Hospital
Kochi, Kôti, 780-0051, Japan
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Tatsuoka Neurology Clinic
Kyoto Shimojo-ku, 680-8811, Japan
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Tokyo headache clinic
Shibuya-Ku, Tokyo, 151-0051, Japan
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Tominaga Hospital
Osaka, Ã"saka, 556-0017, Japan
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Toyota Memorial Hospital
Toyota-shi, 471-8513, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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