A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
Key facts
- Where
- Amherst, Ann Arbor, Atlanta, Baltimore, Charlotte, Cincinnati, Commack, Gainesville, Grand Rapids, Gulf Breeze, Hialeah, Huntington, Lexington, Loxahatchee Groves, New Haven, Norfolk, Oklahoma City, San Antonio, Stamford, Tacoma, Tampa, and Washington D.C., United StatesSee the 22 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 United States
- Dent Neurosciences Research CenterAmherst, United StatesNo longer taking part
- Michigan Headache & Neurological Institute (MHNI)Ann Arbor, United StatesNo longer taking part
- Clinical Integrative Research Center of Atlanta (CIRCAtl)Atlanta, United StatesNo longer taking part
- University of Maryland - Marlene and Stewart Greenebaum Cancer CenterBaltimore, United StatesNo longer taking part
- OnSite Clinical Solutions, LLC - CharlotteCharlotte, United StatesNo longer taking part
- Cincinnati Children's Hospital Medical Center-Burnet CampusCincinnati, United StatesTaking people
- True North Neurology - Commack (North Suffolk Neurology)Commack, United StatesNo longer taking part
- Sarkis Clinical Trials - GainsvilleGainesville, United StatesNo longer taking part
- Corewell Health - Butterworth HospitalGrand Rapids, United StatesNo longer taking part
- NW FL Clinical Research Group, LLCGulf Breeze, United StatesTaking people
- AGA Clinical TrialsHialeah, United StatesTaking people
- Marshall Health-Marshall University Medical CenterHuntington, United StatesTaking people
- UK HealthCare-Kentucky ClinicLexington, United StatesTaking people
- Axcess Medical Research - LoxahatcheeLoxahatchee Groves, United StatesNo longer taking part
- Yale-New Haven Children's HospitalNew Haven, United StatesNo longer taking part
- Children's Specialty Group (CSG)Norfolk, United StatesTaking people
- University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Oklahoma Cancer CenterOklahoma City, United StatesNo longer taking part
- Road Runner Research (RRR)San Antonio, United StatesTaking people
- New England Institute for Clinical Research (NEICR) - StamfordStamford, United StatesTaking people
- MultiCare Mary Bridge Children's Hospital and Health CenterTacoma, United StatesNo longer taking part
- University of South Florida (USF) - Tampa CampusTampa, United StatesTaking people
- Children's National Hospital - Children's National Heart CenterWashington D.C., United StatesNo 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).