This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.
This is an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled Phase III study, to confirm the efficacy and safety of eptinezumab in participants with chronic migraine who are eligible for preventive treatment. participants will be randomly allocated to one of three treatment groups: eptinezumab 300 mg, eptinezumab 100 mg, or placebo. The double-blind, placebo-controlled treatment period will be followed by an extension period where all participants will receive active treatment to further assess the safety and tolerability of eptinezumab. The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks), and a Safety Follow-up Period (8 weeks).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
981
0.9% normal saline, intravenously
Solution for infusion, intravenously
Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12)
Time frame: Weeks 1-12
Response: ≥50% reduction from baseline in MMDs (Weeks 1-12)
Time frame: Weeks 1-12
Response: ≥75% reduction from baseline in MMDs (Weeks 1-4)
Time frame: Weeks 1-4
Response: ≥75% reduction from baseline in MMDs, (Weeks 1-12)
Time frame: Weeks 1-12
Migraine rate on the day after dosing
Time frame: Day 1
Response: ≥50% reduction from baseline in monthly headache days (MHDs) (Weeks 1-12)
Time frame: Weeks 1-12
Change from baseline in the number of MHDs (Weeks 1-12)
Time frame: Weeks 1-12
Response: ≥75% reduction from baseline in MHDs (Weeks 1-4)
Time frame: Weeks 1-4
Change from baseline in rate of migraines with severe pain intensity (Weeks 1-12)
Time frame: Weeks 1-12
Change from baseline in rate of headaches with severe pain intensity (Weeks 1-12)
Time frame: Weeks 1-12
Change from baseline in the number of MMDs with use of acute medication (Weeks 1-12)
Time frame: Weeks 1-12
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The First Medical Center of The Chinese PLA General Hospital (301 Hospital)
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus
Guangzhou, Guangdong, China
People's Hospital of Zhengzhou
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University - Main Campus
Wuhan, Hubei, China
Beijing Chaoyang Hospital Capital Medical University
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
The First Affiliated Hospital With Nanjing Medical University(Jiangsu Province Hospital)
Beijing, China
The First Hospital of Jilin University
Changchun, China
The Second Norman Bethune Hospital of Jilin University - Ziqiang Campus
Changchun, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
...and 77 more locations
Patient Global Impression of Change (PGIC) score at week 12
Time frame: Week 12
Most Bothersome Symptom (MBS) score at Week 12, as measured relative to Screening
Time frame: Screening to Week 12
Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score
Time frame: Baseline to Week 12
Change from baseline to Week 12 in the Migraine-Specific Quality of Life (MSQ v2.1) sub-scores (Role Function-Restrictive, Role Function-Preventive, Emotional Function)
Time frame: Baseline to Week 12
Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score
Time frame: Baseline to Week 12
Health Care Resources Utilization (HCRU)
Migraine-specific healthcare resource utilization information will be collected in terms of outpatient health care professional visits, emergency room visits, hospital admissions, as well as duration of hospital stays.
Time frame: Baseline to Week 12
Change from baseline to Week 12 in the Work Productivity and Activity Impairment Questionnaire: Migraine (WPAI:M) sub-scores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment)
Time frame: Baseline to Week 12