Back to search results

A Study of Eptinezumab for Chronic Migraine in Adolescents

This study is testing eptinezumab, a monoclonal antibody, to see if it can reduce the number of monthly migraine days in young people aged 12 to 17 who have chronic migraine. Participants will receive either eptinezumab or a placebo (an inactive substance like normal saline solution) through an IV. The main goal is to compare how much the number of migraine days changes from the start of the study over 12 weeks. The study is currently recruiting 285 participants, but its status is unclear.

Study design
This is an interventional study with 285 planned participants. It involves a double-blind, placebo-controlled period where participants are randomly assigned to receive eptinezumab or placebo.
What's involved
You would have a 4-week screening period, followed by a single intravenous (IV) infusion of the study drug. You would also need to complete a headache eDiary for at least 23 of 28 days during screening.
Compensation
Not stated in the trial record.
Follow-up
There is an 8-week safety follow-up period after the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04965675

A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine

Recruiting
PHASE3Ages 12–17InterventionalTreatment
H. Lundbeck A/S
~285 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:EptinezumabPlacebo

At a glance

Recruiting sites
53 of 83 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
Measured over Baseline, Weeks 1-12

Conditions

Chronic Migraine in Children

Explore related trials

Chronic Migraine

Where it's being run

83 sites across 55 states
Florida5
Serbia4
Turkey (Türkiye)4
Argentina3
Mexico3
Spain3
Connecticut2
Michigan2

Study leadership

  • Email contact via H. Lundbeck A/S · STUDY_DIRECTOR · H. Lundbeck A/S

Who to contact

Email contact via H. Lundbeck A/S
[email protected]
+45 36301311
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.
During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.

Exclusion

The participant has previously been randomised in this study and exposed to eptinezumab.
The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \<6 months prior to the screening visit.
The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \<6 months prior to the screening visit.
The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \>60 minutes).

What this trial measures

  • Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12Baseline, Weeks 1-12