Estudio intervencional, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo para evaluar la eficacia y seguridad de eptinezumab intravenoso (IV) en pacientes pediátricos (6 a 17 años) para el tratamiento preventivo de la migraña episódica

ReclutandoFase 3ClinicalTrials.gov

ID: NCT05897320Tipo: INTERVENTIONALInicio: 8 de jun de 2023Fin estimado: 31 de ago de 2027

Resumen

El objetivo principal de este ensayo clínico es determinar si eptinezumab ayuda a reducir el número de días con migraña episódica en participantes pediátricos.

Elegibilidad

Edad mínima: 6 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

drug

Eptinezumab

Solution for infusion

drug

Placebo

Solution for infusion

Ubicaciones

Clínica Privada Independencia

Munro, Buenos Aires, Argentina

COMPLETED

Hospital Britanico de Buenos Aires

Barracas, Ciudad Autónoma de BuenosAires, Argentina

COMPLETED

Expertia S.A- Mautalén Salud e Investigación

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

COMPLETED

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

RECRUITING

INECO Neurociencias Oroño

Rosario, Santa Fe Province, Argentina

RECRUITING

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, Argentina

RECRUITING

Hospital de Niños de La Santisima Trinidad

Córdoba, Argentina

RECRUITING

Patrocinadores

PrincipalH. Lundbeck A/S

Contactos

Email contact via H. Lundbeck A/S

CONTACT

HQ_Medinfo@Lundbeck.com +45 36301311

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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