NCT04152083

A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine

A Parallel Group, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Subjects Experiencing an Acute Attack of Migraine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in participants experiencing an acute attack of migraine.

Detailed description

This will be a parallel group, double-blind, randomized, placebo-controlled study assessing the efficacy of eptinezumab for acute migraine, defined as an active intercurrent migraine occurring in those participants who are candidates for preventive therapy. Participants will be randomized to receive a single dose of eptinezumab or placebo in a 1:1 ratio. The total study duration will be approximately 4 to 12 weeks, including up to an 8-week screening period and 4-week of safety follow-up, with clinic visits occurring on Screening, Day 0 (dosing day), and Week 4.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Eptinezumab	Injection for IV administration
DRUG	Placebo	Injection for IV administration

Timeline

• Start date: 2019-11-07
• Primary completion: 2020-07-08
• Completion: 2020-07-08
• First posted: 2019-11-05
• Last updated: 2021-08-17
• Results posted: 2021-08-16

Locations

57 sites across 2 countries: United States, Georgia

Regulatory

• FDA-regulated drug study