Back to resultsA Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab
Primary Purpose
Migraine in Children, Migraine
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Eptinezumab
Sponsored by
About this trial
This is an interventional treatment trial for Migraine in Children
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
Sites / Locations
- New England Institute for Clinical Research
- NW FL Clinical Research Group LLC
- The Premiere Research Institute at Palm Beach Neurology
- College Park Family Care Center
- Michigan Head Pain and Neurological Institute
- Preferred Primary Care Physicians Inc.
- North Texas Institute of Neurology & Headache
- Road Runner Research Ltd
- Wasatch Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Eptinezumab
Arm Description
Outcomes
Primary Outcome Measures
Area under curve (AUC) (0-infinity) eptinezumab
Area under the plasma concentration curve for eptinezumab from zero to infinity
Cmax eptinezumab
Maximum observed plasma concentration of eptinezumab
Secondary Outcome Measures
Clearance (CL)
Plasma clearance
Volume of distribution (Vz)
Development of anti-eptinezumab antibodies (ADA)
Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04537429
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
August 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lundbeck A/S
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine in Children, Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Eptinezumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Eptinezumab
Intervention Description
up to four iv infusions of eptinezumab
Primary Outcome Measure Information:
Title
Area under curve (AUC) (0-infinity) eptinezumab
Description
Area under the plasma concentration curve for eptinezumab from zero to infinity
Time Frame
From dosing to week 20
Title
Cmax eptinezumab
Description
Maximum observed plasma concentration of eptinezumab
Time Frame
From dosing to week 20
Secondary Outcome Measure Information:
Title
Clearance (CL)
Description
Plasma clearance
Time Frame
From dosing to week 20
Title
Volume of distribution (Vz)
Time Frame
From dosing to week 20
Title
Development of anti-eptinezumab antibodies (ADA)
Time Frame
From screening to week 12
Title
Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb)
Time Frame
From screening to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@Lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
NW FL Clinical Research Group LLC
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
The Premiere Research Institute at Palm Beach Neurology
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407-3234
Country
United States
Facility Name
College Park Family Care Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Preferred Primary Care Physicians Inc.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236-4604
Country
United States
Facility Name
North Texas Institute of Neurology & Headache
City
Frisco
State/Province
Texas
ZIP/Postal Code
75034
Country
United States
Facility Name
Road Runner Research Ltd
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Wasatch Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
12. IPD Sharing Statement
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A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab
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