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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05064371
• Other study ID #: 19140B
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 21, 2021
• Est. completion date: June 10, 2024

Study information

• Verified date: August 2023
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 158
• Est. completion date: June 10, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Eptinezumab
Concentrate for solution for IV infusion

Locations

Country	Name	City	State
Japan	Moriyama Neurological Center Hospital	Edogawa-Ku	Tokyo
Japan	DOI Clinic Internal Medicine	Hiroshima-Shi Naka-Ku	Hirosima
Japan	Nagamitsu Clinic	Hofu-Shi	Yamaguti
Japan	Atsuchi Neurosurgery Hospital	Kagoshima-Shi	Kagosima
Japan	Ikeda Neurosurgery	Kasuga-Shi	Hukuoka
Japan	Jinnouchi Neurosurgery Clinic	Kasuga-Shi	Hukuoka
Japan	Shin Matsudakai Atago Hospital	Kochi	Kôti
Japan	Tatsuoka Neurology Clinic	Kyoto Shimojo-ku
Japan	Dokkyo Medical University Hospital	Mibu-machi
Japan	Mito Kyodo General Hospital	Mito	Ibaraki
Japan	Iwate Medical University Uchimaru Medical Center	Morioka-Shi	Iwate
Japan	Tominaga Hospital	Osaka-Shi	Ã"saka
Japan	Saitama Neuropsychiatric Institute	Saitama-Shi	Saitama
Japan	Sendai Headache and Cranial Nerves Clinic	Sendai-Shi Taihaku-Ku	Miyagi
Japan	Tokyo headache clinic	Shibuya-Ku	Tokyo
Japan	Japanese Red Cross Shizuoka Hospital	Shizuoka-shi
Japan	Toyota Memorial Hospital	Toyota-shi

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs)		From Baseline to Week 68
Secondary	Change From Baseline in the Number of Monthly Migraine Days		Baseline, Week 60
Secondary	Response: Number of Participants With =50% Reduction From Baseline in Monthly Migraine Days (MMDs)		Baseline to Week 60
Secondary	Change From Baseline in the Headache Impact Test (HIT-6) Score		Baseline, Week 60
Secondary	Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score		Baseline, Week 60
Secondary	Patient Global Impression of Change (PGIC) Score		Baseline to Week 60
Secondary	Change From Baseline in the Most Bothersome Symptom (MBS) Score		Baseline, Week 60