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

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

Study Overview

• Status: Completed
• Conditions: Migraine; Migraine in Children
• Intervention / Treatment: Drug: Eptinezumab

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • New England Institute for Clinical Research
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • NW FL Clinical Research Group LLC
    • West Palm Beach, Florida, United States, 33407-3234
      • The Premiere Research Institute at Palm Beach Neurology
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • College Park Family Care Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head Pain and Neurological Institute
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236-4604
      • Preferred Primary Care Physicians Inc.
  • Texas
    • Frisco, Texas, United States, 75034
      • North Texas Institute of Neurology & Headache
    • San Antonio, Texas, United States, 78249
      • Road Runner Research Ltd
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eptinezumab	Drug: Eptinezumab; up to four iv infusions of eptinezumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under curve (AUC) (0-infinity) eptinezumab	Area under the plasma concentration curve for eptinezumab from zero to infinity	From dosing to week 20
Cmax eptinezumab	Maximum observed plasma concentration of eptinezumab	From dosing to week 20

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clearance (CL)	Plasma clearance	From dosing to week 20
Volume of distribution (Vz)		From dosing to week 20
Development of anti-eptinezumab antibodies (ADA)		From screening to week 12
Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb)		From screening to week 12

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): October 20, 2022
• Study Completion (Actual): August 21, 2023

Study Registration Dates

• First Submitted: August 28, 2020
• First Submitted That Met QC Criteria: August 28, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: 18922A

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No