RECRUITINGPhase 3INTERVENTIONAL
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine
About This Trial
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
Who May Be Eligible (Plain English)
Who May Qualify:
- Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.
- During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.
- During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.
Who Should NOT Join This Trial:
- History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \>60 min).
- History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.
- Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.
- Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.
Other inclusion and exclusion criteria may apply.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.
* During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.
* During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.
Exclusion Criteria:
* History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \>60 min).
* History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.
* Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.
* Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.
Other inclusion and exclusion criteria may apply.
Treatments Being Tested
DRUG
Eptinezumab
Solution for infusion
DRUG
Placebo
Solution for infusion
Locations (20)
Ki Health Partners LLC DBA New England Institute for Clinical Research
Stamford, Connecticut, United States
Child Neurology of NW Florida
Gulf Breeze, Florida, United States
AGA Clinical Trials
Hialeah, Florida, United States
University of South Florida - 13330 USF Laurel Dr
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 School of Medicine
Baltimore, Maryland, United States
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
North Suffolk Neurology-Commack
Commack, New York, United States
OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte
Charlotte, North Carolina, United States
Childrens Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center - PIN
Cincinnati, Ohio, United States
Road Runner Research Ltd
San Antonio, Texas, United States
Children's Specialty Group - 3 Commercial Place
Norfolk, Virginia, United States
Childrens Hospital of Wisconsin - PIN
New Berlin, Wisconsin, United States
Clínica Privada Independencia
Munro, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
Barracas, Ciudad Autónoma de BuenosAires, Argentina
Expertia S.A- Mautalén Salud e Investigación
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
Instituto Médico Río Cuarto
Río Cuarto, Córdoba Province, Argentina
INECO Neurociencias Oroño
Rosario, Santa Fe Province, Argentina