Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan
- Registration Number
- NCT05064371
- Lead Sponsor
- H. Lundbeck A/S
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Eptinezumab 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) From Baseline to Week 68
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (17)
DOI Clinic Internal Medicine
🇯🇵Hiroshima-Shi Naka-Ku, Hirosima, Japan
Mito Kyodo General Hospital
🇯🇵Mito, Ibaraki, Japan
Saitama Neuropsychiatric Institute
🇯🇵Saitama-Shi, Saitama, Japan
Jinnouchi Neurosurgery Clinic
🇯🇵Kasuga-Shi, Hukuoka, Japan
Sendai Headache and Cranial Nerves Clinic
🇯🇵Sendai-Shi Taihaku-Ku, Miyagi, Japan
Ikeda Neurosurgical Clinic
🇯🇵Kasuga-Shi, Hukuoka, Japan
Iwate Medical University Uchimaru Medical Center
🇯🇵Morioka-Shi, Iwate, Japan
Toyota Memorial Hospital
🇯🇵Toyota-shi, Japan
Shin Matsudakai Atago Hospital
🇯🇵Kochi, Kôti, Japan
Moriyama Neurological Center Hospital
🇯🇵Edogawa-Ku, Tokyo, Japan
Tokyo headache clinic
🇯🇵Shibuya-Ku, Tokyo, Japan
Atsuchi Neurosurgery Hospital
🇯🇵Kagoshima-Shi, Kagosima, Japan
Nagamitsu Clinic
🇯🇵Hofu-Shi, Yamaguti, Japan
Tatsuoka Neurology Clinic
🇯🇵Kyoto Shimojo-ku, Japan
Dokkyo Medical University Hospital
🇯🇵Mibu-machi, Japan
Japanese Red Cross Shizuoka Hospital
🇯🇵Shizuoka-shi, Japan
Tominaga Hospital
🇯🇵Osaka-Shi, Ã"saka, Japan