Clinical trial NCT05064371: Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan
Official title: Interventional, Open-label, Fixed-dose, Long-term Extension Study to Evaluate Safety of Eptinezumab as Preventive Treatment in Patients With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2021-10-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From Baseline to Week 68
Secondary outcomes:
measure: Change From Baseline in the Number of Monthly Migraine Days
timeFrame: Baseline, Week 60
measure: Response: Number of Participants With ≥50% Reduction From Baseline in Monthly Migraine Days (MMDs)
timeFrame: Baseline to Week 60
measure: Change From Baseline in the Headache Impact Test (HIT-6) Score
timeFrame: Baseline, Week 60
measure: Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) Score
timeFrame: Baseline, Week 60
measure: Patient Global Impression of Change (PGIC) Score
timeFrame: Baseline to Week 60
measure: Change From Baseline in the Most Bothersome Symptom (MBS) Score
timeFrame: Baseline, Week 60
Other outcomes:
Locations:
city: Hiroshima-Shi Naka-Ku
country: Japan
facility: DOI Clinic Internal Medicine
state: Hirosima
city: Kasuga-Shi
country: Japan
facility: Jinnouchi Neurosurgery Clinic
state: Hukuoka
city: Kasuga-Shi
country: Japan
facility: Ikeda Neurosurgical Clinic
state: Hukuoka
city: Mito
country: Japan
facility: Mito Kyodo General Hospital
state: Ibaraki
city: Morioka-Shi
country: Japan
facility: Iwate Medical University Uchimaru Medical Center
state: Iwate
city: Kagoshima-Shi
country: Japan
facility: Atsuchi Neurosurgery Hospital
state: Kagosima
city: Kochi
country: Japan
facility: Shin Matsudakai Atago Hospital
state: Kôti
city: Sendai-Shi Taihaku-Ku
country: Japan
facility: Sendai Headache and Cranial Nerves Clinic
state: Miyagi
city: Saitama-Shi
country: Japan
facility: Saitama Neuropsychiatric Institute
state: Saitama
city: Edogawa-Ku
country: Japan
facility: Moriyama Neurological Center Hospital
state: Tokyo
city: Shibuya-Ku
country: Japan
facility: Tokyo headache clinic
state: Tokyo
city: Hofu-Shi
country: Japan
facility: Nagamitsu Clinic
state: Yamaguti
city: Kyoto Shimojo-ku
country: Japan
facility: Tatsuoka Neurology Clinic
city: Mibu-machi
country: Japan
facility: Dokkyo Medical University Hospital
city: Shizuoka-shi
country: Japan
facility: Japanese Red Cross Shizuoka Hospital
city: Toyota-shi
country: Japan
facility: Toyota Memorial Hospital
city: Osaka-Shi
country: Japan
facility: Tominaga Hospital
state: Ã"saka
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: