Migraine
Conditions
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).
Interventions
DRUGEptinezumab
Concentrate for solution for IV infusion
Sponsors
H. Lundbeck A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) | From Baseline to Week 68 |
Secondary
| Measure | Time frame |
|---|---|
| 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 Headache Impact Test (HIT-6) Score | Baseline, Week 60 |
| 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 Most Bothersome Symptom (MBS) Score | Baseline, Week 60 |
Countries
Japan
Outcome results
None listed