Clincosm LogoSign in Get a demo

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

Sponsor
H. Lundbeck A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04537429
Collaborator
(none)
32
Enrollment
9
Locations
1
Arm
31.9
Anticipated Duration (Months)
3.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Aug 3, 2020
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Eptinezumab

Drug: Eptinezumab
up to four iv infusions of eptinezumab

Outcome Measures

Primary Outcome Measures

  1. Area under curve (AUC) (0-infinity) eptinezumab [From dosing to week 20]

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

  2. Cmax eptinezumab [From dosing to week 20]

    Maximum observed plasma concentration of eptinezumab

Secondary Outcome Measures

  1. Clearance (CL) [From dosing to week 20]

    Plasma clearance

  2. Volume of distribution (Vz) [From dosing to week 20]

  3. Development of anti-eptinezumab antibodies (ADA) [From screening to week 12]

  4. Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb) [From screening to week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • H. Lundbeck A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT04537429
Other Study ID Numbers:
  • 18922A
First Posted:
Sep 3, 2020
Last Update Posted:
Aug 11, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Migraine Disorders

Study Results

No Results Posted as of Aug 11, 2022