NCT04537429

A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab

An Open-label, Single-dose, Pharmacokinetic Study to Evaluate IV Eptinezumab in Children and Adolescents With Migraine, Followed by an Optional, Multiple-dose, Open-label Extension Period

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.

Detailed description

This is an interventional, open-label pharmacokinetic study with eptinezumab, consisting of a single-dose, 20-week main study period (Part A) and an optional 44-week multiple-dose extension period (Part B). The main study period includes a single IV infusion of eptinezumab. The optional extension period includes 3 additional eptinezumab infusions 12 weeks apart (reflecting recommended dosing interval in adults), for a total of up to 4 infusions over the course of the study. At least 32 patients with migraine will be enrolled: 16 patients aged 6 to 11 years, and 16 patients aged 12 to 17 years, inclusive.

Conditions

• Migraine in Children
• Migraine

Interventions

Type	Name	Description
DRUG	Eptinezumab	up to four iv infusions of eptinezumab

Timeline

• Start date: 2020-08-04
• Primary completion: 2022-10-20
• Completion: 2023-08-21
• First posted: 2020-09-03
• Last updated: 2023-10-06

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study