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NCT Number: NCT05064371

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DOI Clinic Internal Medicine, Hiroshima-Shi Naka-Ku, Hiroshima, Japan

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Eptinezumab

Drug

Concentrate for solution for IV infusion

Primary outcomes

  1. Number of Participants With Adverse Events (AEs)

    Time frame: From Baseline to Week 68

Secondary outcomes

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

    Time frame: Baseline, Week 60

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

    Time frame: Baseline to Week 60

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

    Time frame: Baseline, Week 60

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

    Time frame: Baseline, Week 60

  5. Patient Global Impression of Change (PGIC) Score

    Time frame: Baseline to Week 60

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

    Time frame: Baseline, Week 60

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 1, 2021
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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