This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication overuse headache
Patients planned for randomization: 91 patients in the eptinezumab 100 mg group and 91 patients in the placebo group. 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 Open-Label Period (12 weeks) and a Safety Follow-up Period (8 weeks). Patient will receive investigational medicinal product (IMP) at the Baseline Visit with either eptinezumab or placebo by IV infusion and at week 12 visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
193
Placebo - solution for infusion
Eptinezumab - 100 mg, solution for infusion
Change from baseline in the number of monthly migraine days (MMDs)
Time frame: Weeks 1-12
Change from baseline in MMDs with use of acute medication
Time frame: Weeks 1-12
Response: ≥50% reduction from baseline in MMDs
Time frame: Weeks 1-12
Migraine rate on the day after dosing
Time frame: At Day 1
Response: ≥75% reduction from baseline in MMDs
Time frame: Weeks 1-4
Change from baseline in the number of monthly headache days (MHDs)
Time frame: Weeks 1-12
Response: ≥75% reduction from baseline in MMDs
Time frame: Weeks 1-12
Response: ≥75% reduction from baseline in MHDs
Time frame: Weeks 1-12
Response: ≥75% reduction from baseline in MHDs
Time frame: Weeks 1-4
Change from baseline in the number of MHDs with use of acute medication
Time frame: Weeks 1-12
Change from baseline in rate of migraines with severe pain intensity
Time frame: Weeks 1-12
Change from baseline in rate of headaches with severe pain intensity
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The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Beijing Chaoyang Hospital Capital Medical University
Beijing, China
Beijing Anzhen Hospital, Capital Medical University
Beijing, China
Peking University First Hospital
Beijing, China
Xuanwu Hospital Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Chinese PLA General Hospital
Beijing, China
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Beijing, China
The First Hospital of Jilin University
Changchun, China
The Second Hospital of Jilin University
Changchun, China
...and 30 more locations
Time frame: Weeks 1-12
Patient Global Impression of Change (PGIC) score
Time frame: At Week 12
Most Bothersome Symptom (MBS) (score as measured relative to Screening)
Time frame: At 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