NCT05452239

A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 608 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Medication overuse headache (MOH) is a type of headache caused by excessive use of acute headache or migraine medications (medications used to treat a headache or migraine once it begins). Treatment of MOH usually involves reducing the dose of or discontinuing acute medications. Eptinezumab is a medication used for the preventive treatment of migraine in adults. The main goals of this trial are to learn whether eptinezumab helps reduce the number of days with migraine, the number of days with headache, and acute medication use in adults who have migraine and MOH.

Detailed description

The total study duration from screening visit to safety follow-up visit is approximately 36 weeks and includes a screening period (4 weeks), a placebo-controlled period (12 weeks), an open-label period (12 weeks), and a safety follow-up period (8 weeks).

Conditions

• Migraine
• Medication Overuse Headache

Interventions

Type	Name	Description
DRUG	Eptinezumab	Solution for infusion
DRUG	Placebo	Solution for infusion

Timeline

• Start date: 2022-07-01
• Primary completion: 2024-10-22
• Completion: 2025-03-13
• First posted: 2022-07-11
• Last updated: 2026-01-29
• Results posted: 2025-12-04

Locations

76 sites across 11 countries: United States, Australia, Denmark, France, Georgia, Germany, Italy, Netherlands, Norway, Spain, Sweden

Regulatory

• FDA-regulated drug study