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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04537429
• Other study ID #: 18922A
• Status: Completed
• Phase: Phase 1
• Start date: August 4, 2020
• Est. completion date: August 21, 2023

Study information

• Verified date: October 2023
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 21, 2023
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• The patient has a diagnosis of migraine with or without aura according to international classification of headache disorders (ICHD)-3 (in the opinion of the investigator) for =6 months prior to the Screening Visit and has a frequency of migraine =4 migraine days per month for at least 3 months prior to the Screening Visit.

Exclusion Criteria:

• The patient has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the Screening Visit.

Other in- and exclusion criteria may apply

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders
• Migraine in Children

Intervention

Drug:
• Eptinezumab
up to four iv infusions of eptinezumab

Locations

Country	Name	City	State
United States	Michigan Head Pain and Neurological Institute	Ann Arbor	Michigan
United States	North Texas Institute of Neurology & Headache	Frisco	Texas
United States	NW FL Clinical Research Group LLC	Gulf Breeze	Florida
United States	College Park Family Care Center	Overland Park	Kansas
United States	Preferred Primary Care Physicians Inc.	Pittsburgh	Pennsylvania
United States	Wasatch Clinical Research	Salt Lake City	Utah
United States	Road Runner Research Ltd	San Antonio	Texas
United States	New England Institute for Clinical Research	Stamford	Connecticut
United States	The Premiere Research Institute at Palm Beach Neurology	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under curve (AUC) (0-infinity) eptinezumab	Area under the plasma concentration curve for eptinezumab from zero to infinity	From dosing to week 20
Primary	Cmax eptinezumab	Maximum observed plasma concentration of eptinezumab	From dosing to week 20
Secondary	Clearance (CL)	Plasma clearance	From dosing to week 20
Secondary	Volume of distribution (Vz)		From dosing to week 20
Secondary	Development of anti-eptinezumab antibodies (ADA)		From screening to week 12
Secondary	Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb)		From screening to week 12