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

NCT ID: NCT04537429

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-04
• Study Completion Date: 2023-08-21

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eptinezumab

Group Type: EXPERIMENTAL

Eptinezumab

Intervention Type: DRUG

up to four iv infusions of eptinezumab

Interventions

Eptinezumab

up to four iv infusions of eptinezumab

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

LundbeckClinicalTrials@Lundbeck.com

Locations

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

College Park Family Care Center

Overland Park, Kansas, United States

Michigan Head Pain and Neurological Institute

Ann Arbor, Michigan, United States

Preferred Primary Care Physicians Inc.

Pittsburgh, Pennsylvania, United States

North Texas Institute of Neurology & Headache

Frisco, Texas, United States

Road Runner Research Ltd

San Antonio, Texas, United States

Wasatch Clinical Research

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

18922A

Identifier Type: -

Identifier Source: org_study_id