Migraine in ChildrenPhase 1NCT04537429
A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab
A Phase 1 study testing Eptinezumab in people with Migraine in Children and Migraine, run by H. Lundbeck A/S at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Migraine in Children, Migraine
- What is being tested?
- Eptinezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 9 sitesUnited States
- Study dates
- 4 Aug 2020to 21 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
North Texas Institute of Neurology & Headache
Frisco, Texas, 75034
NW FL Clinical Research Group LLC
Gulf Breeze, Florida, 32561
College Park Family Care Center
Overland Park, Kansas, 66212
Preferred Primary Care Physicians Inc.
Pittsburgh, Pennsylvania, 15236-4604
Wasatch Clinical Research
Salt Lake City, Utah, 84107
Road Runner Research Ltd
San Antonio, Texas, 78249
New England Institute for Clinical Research
Stamford, Connecticut, 06905
The Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407-3234
About this study
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
The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.
Read the 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
- Being tested
- Eptinezumab
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EptinezumabDrug
up to four iv infusions of eptinezumab
| Study group | Role | What they receive |
|---|---|---|
| Eptinezumab | Experimental | Not described Receives: Drug: Eptinezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) (0-infinity) eptinezumab
Area under the plasma concentration curve for eptinezumab from zero to infinity
Measured: From dosing to week 20
Cmax eptinezumab
Maximum observed plasma concentration of eptinezumab
Measured: From dosing to week 20
Secondary outcomes (4)
Clearance (CL)
Plasma clearance
Measured: From dosing to week 20
Volume of distribution (Vz)
Measured: From dosing to week 20
Development of anti-eptinezumab antibodies (ADA)
Measured: From screening to week 12
Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb)
Measured: From screening to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start4 Aug 2020
- Primary completion20 Oct 2022
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Migraine in ChildrenStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537429
- Sponsor's protocol ID
- 18922A
- Status last verified
- Oct 2023
- First submitted
- 28 Aug 2020
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hershey AD, Areberg J, Boserup LP, Lindsten A, Rosen M. Pharmacokinetics and safety of eptinezumab in children and adolescents with migraine. Headache. 2025 Oct;65(9):1573-1583. doi: 10.1111/head.14959. Epub 2025 May 30.
PubMed 40444655
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04537429
- Acronym / sponsor ID
- 18922A
- Conditions
- Migraine in Children, Migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eptinezumab | Experimental | Drug: Eptinezumab |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eptinezumabup to four iv infusions of eptinezumab | Drug | Eptinezumab |
Primary outcome
Area under curve (AUC) (0-infinity) eptinezumab
Time frame: From dosing to week 20
Area under the plasma concentration curve for eptinezumab from zero to infinity
Cmax eptinezumab
Time frame: From dosing to week 20
Maximum observed plasma concentration of eptinezumab
4 secondary outcomes
Clearance (CL)
Time frame: From dosing to week 20
Volume of distribution (Vz)
Time frame: From dosing to week 20
Development of anti-eptinezumab antibodies (ADA)
Time frame: From screening to week 12
Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb)
Time frame: From screening to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Derived from this study: PubMed 40444655Hershey AD, Areberg J, Boserup LP, Lindsten A, Rosen M. Pharmacokinetics and safety of eptinezumab in children and adolescents with migraine. Headache. 2025 Oct;65(9):1573-1583. doi: 10.1111/head.14959. Epub 2025 May 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eptinezumab in people with Migraine in Children and Migraine, run by H. Lundbeck A/S at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under curve (AUC) (0-infinity) eptinezumab (time frame: From dosing to week 20). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04537429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.