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

Sponsor

H. Lundbeck A/S (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05064371

Collaborator

(none)

100

Enrollment

Locations

Arm

32.6

Anticipated Duration (Months)

5.9

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Migraine	Drug: Eptinezumab	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 21, 2021

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 10, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of Participants With Adverse Events (AEs) [From Baseline to Week 68]

Secondary Outcome Measures

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]
Change From Baseline in the Most Bothersome Symptom (MBS) Score [Baseline, Week 60]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DOI Clinic Internal Medicine	Hiroshima-Shi Naka-Ku	Hirosima	Japan	730-0031
2	Jinnouchi Neurosurgery Clinic	Kasuga-Shi	Hukuoka	Japan	816-0802
3	Ikeda Neurosurgery	Kasuga-Shi	Hukuoka	Japan	816-0824
4	Mito Kyodo General Hospital	Mito	Ibaraki	Japan	310-0015
5	Iwate Medical University Uchimaru Medical Center	Morioka-Shi	Iwate	Japan	020-0023
6	Atsuchi Neurosurgery Hospital	Kagoshima-Shi	Kagosima	Japan	892-0842
7	Shin Matsudakai Atago Hospital	Kochi	Kôti	Japan	780-0051
8	Sendai Headache and Cranial Nerves Clinic	Sendai-Shi Taihaku-Ku	Miyagi	Japan	982-0014
9	Saitama Neuropsychiatric Institute	Saitama-Shi	Saitama	Japan	338-8577
10	Moriyama Neurological Center Hospital	Edogawa-Ku	Tokyo	Japan	134-0085
11	Tokyo headache clinic	Shibuya-Ku	Tokyo	Japan	151-0051
12	Nagamitsu Clinic	Hofu-Shi	Yamaguti	Japan	747-0802
13	Tatsuoka Neurology Clinic	Kyoto Shimojo-ku		Japan	680-8811
14	Dokkyo Medical University Hospital	Mibu-machi		Japan	321-0293
15	Japanese Red Cross Shizuoka Hospital	Shizuoka-shi		Japan	420-0853
16	Toyota Memorial Hospital	Toyota-shi		Japan	471-8513
17	Tominaga Hospital	Osaka-Shi	Ã"saka	Japan	556-0017

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

H. Lundbeck A/S

ClinicalTrials.gov Identifier:

NCT05064371

Other Study ID Numbers:

19140B

First Posted:

Oct 1, 2021

Last Update Posted:

Jul 15, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Migraine Disorders

Study Results

No Results Posted as of Jul 15, 2022