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Completed

NCT Number: NCT04537429

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

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

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Key information

Conditions

Migraine in Children Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New England Institute for Clinical Research, Stamford, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eptinezumab

Drug

up to four iv infusions of eptinezumab

Primary outcomes

  1. Area under curve (AUC) (0-infinity) eptinezumab

    Time frame: From dosing to week 20

    Area under the plasma concentration curve for eptinezumab from zero to infinity

  2. Cmax eptinezumab

    Time frame: From dosing to week 20

    Maximum observed plasma concentration of eptinezumab

Secondary outcomes

  1. Clearance (CL)

    Time frame: From dosing to week 20

    Plasma clearance

  2. Volume of distribution (Vz)

    Time frame: From dosing to week 20

  3. Development of anti-eptinezumab antibodies (ADA)

    Time frame: From screening to week 12

  4. Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb)

    Time frame: From screening to week 12

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Sep 3, 2020
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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