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

RecruitingPhase 3

Sponsor: H. Lundbeck A/S

Conditions: Chronic Migraine in Children

Interventions: Eptinezumab, Placebo

Countries: United States, Argentina, Canada, Italy, Mexico, Poland, Portugal, Serbia

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 overview

Sex: ALL

Age: 12 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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).

Locations (83)

New Haven, Connecticut, United States
Stamford, Connecticut, United States
Washington D.C., District of Columbia, United States
Gainesville, Florida, United States
Gulf Breeze, Florida, United States
Hialeah, Florida, United States
Loxahatchee Groves, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Lexington, Kentucky, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
Amherst, New York, United States
Commack, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Oklahoma City, Oklahoma, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Tacoma, Washington, United States
Huntington, West Virginia, United States
Mar del Plata, Buenos Aires, Argentina
Munro, Buenos Aires, Argentina
Córdoba, Cordoba, Argentina, Argentina
Córdoba-Barrio Crisol, Córdoba Province, Argentina
Río Cuarto, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Buenos Aires, Argentina
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