NCT04965675 A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
| NCT ID | NCT04965675 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | H. Lundbeck A/S |
| Condition | Chronic Migraine in Children |
| Study Type | INTERVENTIONAL |
| Enrollment | 285 participants |
| Start Date | 2021-06-30 |
| Primary Completion | 2026-09-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 285 participants in total. It began in 2021-06-30 with a primary completion date of 2026-09-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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).
Contact & Investigator
Email contact via H. Lundbeck A/S
STUDY DIRECTOR
H. Lundbeck A/S
Frequently Asked Questions
Who can join the NCT04965675 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Chronic Migraine in Children. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04965675 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 285 participants.
Is NCT04965675 currently recruiting?
Yes, NCT04965675 is actively recruiting participants. Contact the research team at HQ_Medinfo@Lundbeck.com for enrollment information.
Where is the NCT04965675 trial being conducted?
This trial is being conducted at New Haven, United States, Stamford, United States, Washington D.C., United States, Gainesville, United States and 11 additional locations.
Who is sponsoring the NCT04965675 clinical trial?
NCT04965675 is sponsored by H. Lundbeck A/S. The principal investigator is Email contact via H. Lundbeck A/S at H. Lundbeck A/S. The trial plans to enroll 285 participants.
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