A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
Key facts
- Where
- Cagliari, Florence, Genoa, Milan, Pavia, and Rome, ItalySee the 7 sites
- Phase
- Phase 3
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 Italy
- Azienda Socio Sanitaria Locale N. 8 Di CagliariCagliari, ItalyNo longer taking part
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyNo longer taking part
- IRCCS Istituto Giannina GasliniGenoa, ItalyNo longer taking part
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, ItalyNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, ItalyNo longer taking part
- Fondazione Istituto Neurologico Nazionale Casimiro MondinoPavia, ItalyNo longer taking part
- Ospedale Pediatrico Bambino GesùRome, ItalyNo 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).