RECRUITINGPhase 3INTERVENTIONAL
A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine
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
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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).
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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).
Treatments Being Tested
DRUG
Eptinezumab
Eptinezumab will be administered per dose and schedule specified in the arm.
DRUG
Placebo
Placebo matching to eptinezumab will be administered per schedule specified in the arm.
Locations (20)
Yale-New Haven Children's Hospital - PIN
New Haven, Connecticut, United States
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
NW FL Clinical Research Group, LLC
Gulf Breeze, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
Axcess Medical Research
Loxahatchee Groves, Florida, United States
University of South Florida
Tampa, Florida, United States
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, United States
University of Kentucky HealthCare (UKHC) Kentucky Clinic
Lexington, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Michigan State University - Department of Neurology
East Lansing, Michigan, United States
Corewell Health Butterworth Hospital
Grand Rapids, Michigan, United States
Dent Neurosciences Research Center Incorporated
Amherst, New York, United States
North Suffolk Neurology-Commack
Commack, New York, United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
Charlotte, North Carolina, United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Road Runner Research Ltd
San Antonio, Texas, United States
Children's Specialty Group
Norfolk, Virginia, United States