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Eptinezumab in migraine with medication overuse headache
NCT05452239Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2022
- Primary completion
- Oct 2024
- Countries
- 11
- Sponsor
- Lundbeck
- Modality
- Recombinant Proteins and Enzymes, Monoclonal Antibodies
- Drugs
- eptinezumab
- Conditions
- migraine
01
Overview
Phase 4, randomised, double-blind trial in migraine comparing Eptinezumab with Placebo (2 arms). Primary endpoint: Monthly Migraine Days. Started Jul 2022; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Eptinezumab
Participants receive eptinezumab IV infusion at Week 0 and Week 12
Placebo
Participants receive placebo IV infusion at Week 0, then eptinezumab IV infusion at Week 12
03
Who it enrols
Adults with migraine and medication overuse headache, with ≥8 migraine days and ≥15 headache days per month for the past 3 months, migraine onset at ≤50 years of age, excluding those with confounding pain syndromes, certain headache types, uncontrolled psychiatric conditions, or significant cardiovascular disease
04
Endpoints
Primary
Monthly Migraine Days
Secondary
Monthly Migraine Days
Monthly Headache Days
Percentage Not Fulfilling ICHD-3 Criteria for Chronic Migraine or Medication Overuse Headache
Average Daily Pain Assessment
Monthly Days With Acute Migraine Medication Use
Percentage Not Fulfilling ICHD-3 Criteria for Chronic Migraine
Percentage Not Fulfilling ICHD-3 Criteria for Medication Overuse Headache
Monthly Migraine Days With Use of Acute Headache Medication
05
Results
Primary endpoints met
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