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MigrainePhase 3NCT05064371

Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

A Phase 3 study testing Eptinezumab in people with Migraine, run by H. Lundbeck A/S at 17 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is an open label extension study, which means that the participants from the Lead-in Study 19140A (NCT04921384) can join this study, if they meet the study Eligibility Criteria, and continue to receive the study drug eptinezumab. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Migraine
What is being tested?
Eptinezumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
17 sitesJapan
Study dates
21 Sep 2021to 8 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Japan17 sites

  • Moriyama Neurological Center Hospital

    Edogawa-Ku, Tokyo, 134-0085

  • DOI Clinic Internal Medicine

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

  • Nagamitsu Clinic

    Hofu-Shi, Yamaguchi, 747-0802

  • Atsuchi Neurosurgery Hospital

    Kagoshima, Kagoshima-ken, 892-0842

  • Jinnouchi Neurosurgery Clinic

    Kasuga-Shi, Hukuoka, 816-0802

  • Ikeda Neurosurgical Clinic

    Kasuga-Shi, Hukuoka, 816-0824

  • Shin Matsudakai Atago Hospital

    Kochi, Kôti, 780-0051

  • Tatsuoka Neurology Clinic

    Kyoto Shimojo-ku, 680-8811

  • Dokkyo Medical University Hospital

    Mibu-machi, 321-0293

  • Mito Kyodo General Hospital

    Mito, Ibaraki, 310-0015

  • Iwate Medical University Uchimaru Medical Center

    Morioka, Iwate, 020-0023

  • Tominaga Hospital

    Osaka, Ã"saka, 556-0017

  • Saitama Neuropsychiatric Institute

    Saitama-Shi, Saitama, 338-8577

  • Sendai Headache and Cranial Nerves Clinic

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

  • Tokyo headache clinic

    Shibuya-Ku, Tokyo, 151-0051

  • Japanese Red Cross Shizuoka Hospital

    Shizuoka, 420-0853

  • Toyota Memorial Hospital

    Toyota-shi, 471-8513

Other trials in Japan

About this study

Official title: Interventional, Open-label, Fixed-dose, Long-term Extension Study to Evaluate Safety of Eptinezumab as Preventive Treatment in Patients With Migraine

This study is an open label extension study, which means that the participants from the Lead-in Study 19140A (NCT04921384) can join this study, if they meet the study Eligibility Criteria, and continue to receive the study drug eptinezumab. The main goal of this study is to investigate long-term safety and tolerability of eptinezumab in Japanese migraine participants.

Read the detailed description

The total study duration from the Baseline Visit to the Safety Follow-up Visit is approximately 68 weeks and includes an Open-Label Treatment Period (60 weeks) and a Safety Follow-up Period (8 weeks).

Conditions
Migraine
Being tested
Eptinezumab
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EptinezumabDrug

    Concentrate for solution for IV infusion

Study groups in NCT05064371
Study groupRoleWhat they receive
EptinezumabExperimentalParticipants will receive eptinezumab 100 milligrams (mg) at the Baseline visit (Week 0) and eptinezumab 100 mg or 300 mg (depending upon the treatment response) at Weeks 12, 24, 36, and 48 by intravenous (IV) infusions.
Receives: Drug: Eptinezumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Adverse Events (AEs)

    Measured: From Baseline to Week 68

Secondary outcomes (6)

  1. Change From Baseline in the Number of Monthly Migraine Days

    Measured: Baseline, Week 60

  2. Response: Number of Participants With ≥50% Reduction From Baseline in Monthly Migraine Days (MMDs)

    Measured: Baseline to Week 60

  3. Change From Baseline in the Headache Impact Test (HIT-6) Score

    Measured: Baseline, Week 60

  4. Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score

    Measured: Baseline, Week 60

  5. Patient Global Impression of Change (PGIC) Score

    Measured: Baseline to Week 60

  6. Change From Baseline in the Most Bothersome Symptom (MBS) Score

    Measured: Baseline, Week 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2021
  2. Study start21 Sep 2021
  3. Primary completion8 Jun 2024
  4. Study completion8 Jun 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05064371
Sponsor's protocol ID
19140B
Status last verified
Jan 2026
First submitted
22 Sep 2021
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Takeshima T, Danno D, Imai N, Suzuki K, Ettrup A, Jensen S, Josiassen MK, Mittoux A, Matsumori Y. Long-term tolerability and effectiveness of eptinezumab in Japanese adults with chronic migraine: results of the 60-week open-label SUNSET trial. J Headache Pain. 2025 Nov 22;26(1):275. doi: 10.1186/s10194-025-02214-w.

    PubMed 41275111

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Eptinezumab in people with Migraine, run by H. Lundbeck A/S at 17 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 2 inclusion and 4 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 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants With Adverse Events (AEs) (time frame: From Baseline to Week 68). 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 NCT05064371, 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 14 Jan 2026.

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