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

NCT05064371 | Completed Phase 3 DMC

• 1 other identifier: 19140B
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 17

Brief 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. The main goal of this study is to investigate long-term safety and tolerability of eptinezumab in Japanese migraine participants.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  From Baseline to Week 68

Secondary Outcomes (6)

• Change From Baseline in the Number of Monthly Migraine Days

  Baseline, Week 60

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

  Baseline to Week 60

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

  Baseline, Week 60

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

  Baseline, Week 60

• Patient Global Impression of Change (PGIC) Score

  Baseline to Week 60

Study Arms (1)

Eptinezumab

EXPERIMENTAL

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

Interventions

Eptinezumab DRUG

Concentrate for solution for IV infusion

Eptinezumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (17)

DOI Clinic Internal Medicine

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

Location

Jinnouchi Neurosurgery Clinic

Kasuga-Shi, Hukuoka, 816-0802, Japan

Location

Ikeda Neurosurgical Clinic

Kasuga-Shi, Hukuoka, 816-0824, Japan

Location

Mito Kyodo General Hospital

Mito, Ibaraki, 310-0015, Japan

Location

Iwate Medical University Uchimaru Medical Center

Morioka, Iwate, 020-0023, Japan

Location

Atsuchi Neurosurgery Hospital

Kagoshima, Kagoshima-ken, 892-0842, Japan

Location

Shin Matsudakai Atago Hospital

Kochi, Kôti, 780-0051, Japan

Location

Sendai Headache and Cranial Nerves Clinic

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

Location

Saitama Neuropsychiatric Institute

Saitama-Shi, Saitama, 338-8577, Japan

Location

Moriyama Neurological Center Hospital

Edogawa-Ku, Tokyo, 134-0085, Japan

Location

Tokyo headache clinic

Shibuya-Ku, Tokyo, 151-0051, Japan

Location

Nagamitsu Clinic

Hofu-Shi, Yamaguchi, 747-0802, Japan

Location

Tatsuoka Neurology Clinic

Kyoto Shimojo-ku, 680-8811, Japan

Location

Dokkyo Medical University Hospital

Mibu-machi, 321-0293, Japan

Location

Japanese Red Cross Shizuoka Hospital

Shizuoka, 420-0853, Japan

Location

Toyota Memorial Hospital

Toyota-shi, 471-8513, Japan

Location

Tominaga Hospital

Osaka, Ã"saka, 556-0017, Japan

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 1, 2021
• Study Start: September 21, 2021
• Primary Completion: June 8, 2024
• Study Completion: June 8, 2024
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

JP (17)