NCT04772742

Eptinezumab in Adults With Migraine and Medication Overuse Headache

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine in Patients With a Dual Diagnosis of Migraine and Medication Overuse Headache

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy of eptinezumab to prevent migraine and headache in patients with the combined diagnosis of migraine and medication overuse headache

Detailed description

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.

Conditions

• Migraine
• Medication Overuse Headache

Interventions

Type	Name	Description
DRUG	Placebo	Placebo - solution for infusion
DRUG	Eptinezumab	Eptinezumab - 100 mg, solution for infusion

Timeline

• Start date: 2021-02-17
• Primary completion: 2022-05-23
• Completion: 2022-09-30
• First posted: 2021-02-26
• Last updated: 2022-10-31

Locations

40 sites across 5 countries: China, Georgia, South Korea, Spain, Taiwan