Eptinezumab infusions to prevent chronic migraine in teenagers
Tests eptinezumab against placebo for preventing migraine days in teenagers with chronic migraine.
Plain-language title generated from the registry record
Registry title: A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
Key facts
- Where
- Barcelona, Madrid, Sevilla, Valencia, and Vigo, SpainSee the 5 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young people aged 12 to 17 who have had chronic migraine for at least 6 months.
- Age
- 12 to 17 years
- Sex
- All sexes can join.
- Disease stage
- Migraine (with or without aura) with a history of chronic migraine for at least 6 months before screening. In the 28-day screening period: 15 to 26 headache days, at least 8 of them migraine days.
- Earlier treatment
- Cannot have had any monoclonal antibody treatment or another CGRP antibody in the 6 months before screening. Cannot have had eptinezumab in this study before.
Main reasons for not taking part
- Took part in this study before and received eptinezumab
- Any monoclonal antibody treatment less than 6 months before screening
- Another CGRP antibody less than 6 months before screening
- History of complicated migraine, chronic tension-type headache, cluster headache or other listed headache types
- Unusual migraine types such as hemiplegic migraine or migraine with brainstem aura
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 17 years old?
Source: NCT04965675, who can take part
Where in Spain
- Hospital Universitari Vall d'HebronBarcelona, SpainNo longer taking part
- Hospital Clínico San CarlosMadrid, SpainNo longer taking part
- University Hospital Virgen Del Rocio S.L.Sevilla, SpainNo longer taking part
- Hospital Universitario Y Politecnico La FeValencia, SpainNo longer taking part
- Hospital Alvaro CunqueiroVigo, SpainNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- H. Lundbeck A/S
- Trial code
- NCT04965675EU 2024-510656-13-00
- Record updated
- 16 October 2026
- Original description
To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.Read full original descriptionShow less
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine
To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.
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).