Clinical Trials in the USA / NCT05897320
Recruiting
Phase 3
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine
NCT05897320 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Episodic Migraine
Investigational drug(s) / intervention(s)
Eptinezumab →Placebo
Eptinezumab: Solution for infusion
Placebo: Solution for infusion
Study summary
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
Eligibility
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.
Primary outcome measure(s)
- Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 — Baseline, Weeks 1-12
Trial sites (60)
| Facility | City | Region | Status |
|---|---|---|---|
| New England Institute for Clinical Research (NEICR) - Stamford | Stamford | Connecticut | Recruiting |
| Child Neurology Center (CNC) of Northwest Florida | Gulf Breeze | Florida | Recruiting |
| AGA Clinical Trials | Hialeah | Florida | Recruiting |
| University of South Florida (USF) - Tampa Campus | Tampa | Florida | Recruiting |
| Clinical Integrative Research Center of Atlanta (CIRCAtl) | Atlanta | Georgia | Completed |
| UK HealthCare-Kentucky Clinic | Lexington | Kentucky | Completed |
| University of Maryland School of Medicine | Baltimore | Maryland | Completed |
| Michigan Headache & Neurological Institute (MHNI) | Ann Arbor | Michigan | Completed |
| True North Neurology - Commack (North Suffolk Neurology) | Commack | New York | Completed |
| OnSite Clinical Solutions, LLC - Charlotte | Charlotte | North Carolina | Completed |
| Akron Children's Hospital | Akron | Ohio | Recruiting |
| Cincinnati Children's Hospital Medical Center-Burnet Campus | Cincinnati | Ohio | Recruiting |
| Road Runner Research (RRR) | San Antonio | Texas | Recruiting |
| Children's Specialty Group (CSG) | Norfolk | Virginia | Recruiting |
| Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus | Milwaukee | Wisconsin | Recruiting |
| Mautalén Salud e Investigación | Buenos Aires | Buenos Aires F.D. | Completed |
| Hospital de Niños de la Santísima Trinidad | Córdoba | Córdoba Province | Recruiting |
| Instituto Médico Río Cuarto | Río Cuarto | Córdoba Province | Recruiting |
| INECO Neurociencias Oroño | Rosario | Santa Fe Province | Recruiting |
| Centro de Investigaciones Medicas Tucuman | San Miguel de Tucumán | Tucumán Province | Recruiting |
| Clinica Independencia | Buenos Aires | Argentina | Completed |
| Hospital Britanico de Buenos Aires (HOB) | Buenos Aires | Argentina | Completed |
| The Medical Arts Health Research Group - Penticton | Penticton | British Columbia | Completed |
| Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic | Victoria | British Columbia | Recruiting |
| Kids Clinic | Ajax | Ontario | Recruiting |
| London Health Sciences Centre (LHSC) | London | Ontario | Recruiting |
| L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret... | Cagliari | South Sardinia | Completed |
| Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare | Genoa | Italy | Recruiting |
| Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta | Milan | Italy | Completed |
| Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico | Pavia | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To... | Pisa | Italy | Recruiting |
| Ospedale Pediatrico Bambino Gesu - Gianicolo | Rome | Italy | Recruiting |
| Centro de Investigacion Clinica de Morelia, S.C. | Morelia | Michoacán | Completed |
| Clinical Research Institute SC-Mexico | Tepetlacolco | Mexico | Recruiting |
| Centrum Medyczne Plejady | Krakow | Lesser Poland Voivodeship | Recruiting |
| Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k | Oświęcim | Lesser Poland Voivodeship | Recruiting |
| ETG Lublin | Lublin | Lublin Voivodeship | Recruiting |
| MTZ Clinical Research Powered by PRATIA | Warsaw | Masovian Voivodeship | Recruiting |
| European Trial group network Sp. z o.o - Neuroscience | Warsaw | Masovian Voivodeship | Recruiting |
| Hospital de Braga | Braga | Portugal | Recruiting |
+ 20 more sites — see the full list on the official registry below.
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Other trials for the same condition
A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults
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A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05897320 on ClinicalTrials.gov ↗ ← All trials in the USA