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

January 13, 2026 updated by: H. Lundbeck A/S

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto Shimojo-ku, Japan, 680-8811
        • Tatsuoka Neurology Clinic
      • Mibu-machi, Japan, 321-0293
        • Dokkyo Medical University Hospital
      • Shizuoka, Japan, 420-0853
        • Japanese Red Cross Shizuoka Hospital
      • Toyota-shi, Japan, 471-8513
        • Toyota Memorial Hospital
    • Hiroshima
      • Hiroshima-Shi Naka-Ku, Hiroshima, Japan, 730-0031
        • DOI Clinic Internal Medicine
    • Hukuoka
      • Kasuga-Shi, Hukuoka, Japan, 816-0802
        • Jinnouchi Neurosurgery Clinic
      • Kasuga-Shi, Hukuoka, Japan, 816-0824
        • Ikeda Neurosurgical Clinic
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0015
        • Mito Kyodo General Hospital
    • Iwate
      • Morioka, Iwate, Japan, 020-0023
        • Iwate Medical University Uchimaru Medical Center
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 892-0842
        • Atsuchi Neurosurgery Hospital
    • Kôti
      • Kochi, Kôti, Japan, 780-0051
        • Shin Matsudakai Atago Hospital
    • Miyagi
      • Sendai-Shi Taihaku-Ku, Miyagi, Japan, 982-0014
        • Sendai Headache and Cranial Nerves Clinic
    • Saitama
      • Saitama-Shi, Saitama, Japan, 338-8577
        • Saitama Neuropsychiatric Institute
    • Tokyo
      • Edogawa-Ku, Tokyo, Japan, 134-0085
        • Moriyama Neurological Center Hospital
      • Shibuya-Ku, Tokyo, Japan, 151-0051
        • Tokyo Headache Clinic
    • Yamaguchi
      • Hofu-Shi, Yamaguchi, Japan, 747-0802
        • Nagamitsu Clinic
    • Ã"saka
      • Osaka, Ã"saka, Japan, 556-0017
        • Tominaga Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Eptinezumab
Participants 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.
Drug: Eptinezumab
Concentrate for solution for IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: From Baseline to Week 68
From Baseline to Week 68

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in the Number of Monthly Migraine Days
Time Frame: Baseline, Week 60
Baseline, Week 60
Response: Number of Participants With ≥50% Reduction From Baseline in Monthly Migraine Days (MMDs)
Time Frame: Baseline to Week 60
Baseline to Week 60
Change From Baseline in the Headache Impact Test (HIT-6) Score
Time Frame: Baseline, Week 60
Baseline, Week 60
Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score
Time Frame: Baseline, Week 60
Baseline, Week 60
Patient Global Impression of Change (PGIC) Score
Time Frame: Baseline to Week 60
Baseline to Week 60
Change From Baseline in the Most Bothersome Symptom (MBS) Score
Time Frame: Baseline, Week 60
Baseline, Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Investigators

  • Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2021

Primary Completion (Actual)

June 8, 2024

Study Completion (Actual)

June 8, 2024

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 1, 2021

Study Record Updates

Last Update Posted (Estimated)

January 14, 2026

Last Update Submitted That Met QC Criteria

January 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19140B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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