Clinical trial NCT04537429: A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Migraine in Children
Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-09-03
Enrollment: 28
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Other in- and exclusion criteria may apply

Primary outcomes:
measure: Area under curve (AUC) (0-infinity) eptinezumab
timeFrame: From dosing to week 20
measure: Cmax eptinezumab
timeFrame: From dosing to week 20
Secondary outcomes:
measure: Clearance (CL)
timeFrame: From dosing to week 20
measure: Volume of distribution (Vz)
timeFrame: From dosing to week 20
measure: Development of anti-eptinezumab antibodies (ADA)
timeFrame: From screening to week 12
measure: Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb)
timeFrame: From screening to week 12
Other outcomes:
Locations:
city: Stamford
country: United States
facility: New England Institute for Clinical Research
state: Connecticut
city: Gulf Breeze
country: United States
facility: NW FL Clinical Research Group LLC
state: Florida
city: West Palm Beach
country: United States
facility: The Premiere Research Institute at Palm Beach Neurology
state: Florida
city: Overland Park
country: United States
facility: College Park Family Care Center
state: Kansas
city: Ann Arbor
country: United States
facility: Michigan Head Pain and Neurological Institute
state: Michigan
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians Inc.
state: Pennsylvania
city: Frisco
country: United States
facility: North Texas Institute of Neurology & Headache
state: Texas
city: San Antonio
country: United States
facility: Road Runner Research Ltd
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research
state: Utah
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: