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

H. Lundbeck A/S28 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Migraine in Children Migraine

Interventions

EptinezumabDRUG

up to four iv infusions of eptinezumab

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (9)

New England Institute for Clinical Research

Stamford, Connecticut, United States

NW FL Clinical Research Group LLC

Gulf Breeze, Florida, United States

The Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, United States

Outcomes

Primary Outcomes

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

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

Time frame: From dosing to week 20

Cmax eptinezumab

Maximum observed plasma concentration of eptinezumab

Time frame: From dosing to week 20

Secondary Outcomes

Clearance (CL)

Plasma clearance

Time frame: From dosing to week 20

Volume of distribution (Vz)

Time frame: From dosing to week 20

Development of anti-eptinezumab antibodies (ADA)

Time frame: From screening to week 12

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

Time frame: From screening to week 12

Data from ClinicalTrials.gov

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