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

Study Overview
=================
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.

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).

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

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Eptinezumab


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eptinezumab<br>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<br>* Concentrate for solution for IV infusion<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |