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
1 other identifier
interventional
28
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2020
Typical duration for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2020
CompletedFirst Submitted
Initial submission to the registry
August 28, 2020
CompletedFirst Posted
Study publicly available on registry
September 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 21, 2023
CompletedOctober 6, 2023
October 1, 2023
2.2 years
August 28, 2020
October 5, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Clearance (CL)
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
Study Arms (1)
Eptinezumab
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- The patient has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the Screening Visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- H. Lundbeck A/Slead
Study Sites (9)
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
NW FL Clinical Research Group LLC
Gulf Breeze, Florida, 32561, United States
The Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407-3234, United States
College Park Family Care Center
Overland Park, Kansas, 66212, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104, United States
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, 15236-4604, United States
North Texas Institute of Neurology & Headache
Frisco, Texas, 75034, United States
Road Runner Research Ltd
San Antonio, Texas, 78249, United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@Lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2020
First Posted
September 3, 2020
Study Start
August 4, 2020
Primary Completion
October 20, 2022
Study Completion
August 21, 2023
Last Updated
October 6, 2023
Record last verified: 2023-10