A Phase 3, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of AMZ002, Compared to Vigabatrin, in the Treatment of Infantile Spasms

RetiradoFase 3ClinicalTrials.gov

ID: NCT05128344Tipo: INTERVENTIONALInicio: 1 de abr de 2023Fin estimado: 1 de dic de 2025

Traducción no disponible, mostrando original

Resumen

The main purpose of this study is to evaluate the efficacy of AMZ002 compared to Vigabatrin in participants with newly diagnosed infantile spasms (IS).

Elegibilidad

Edad mínima: 2 MonthsEdad máxima: 24 MonthsSexo: ALL

Criterios de inclusión

Participant has been diagnosed with IS within 6 weeks prior to Screening. Diagnostic criteria include both clinical spasms and an EEG pattern consistent with hypsarrhythmia or significant abnormality compatible with IS
Participant has normal renal function as defined by an estimated glomerular filtration rate (eGFR) greater than \[\>\] 60 milliliter/minute (mL/min)/1.73 m\^2, calculated as eGFR = 0.413 × (height \[Centimeter (cm)\]/serum creatinine \[milligrams per deciliter {mg/dL}\])
Participant's legally authorized representative (that is \[i.e.\], parent or guardian) must provide written informed consent obtained per Institutional Review Board (IRB) policy and requirements, consistent with the International Council for Harmonisation (ICH)
Participant's parent/guardian is able to understand and willing to comply with study procedures and restrictions

Criterios de exclusión

Participant has been diagnosed with tuberous sclerosis
Participant has acute illness considered clinically significant by the Investigator within 30 days prior to Screening
Participant has a diagnosis of recent systemic fungal infection; history of ocular herpes simplex; history of or current peptic ulcer; uncontrolled hypertension or congestive heart failure; or any other condition that would be significantly impacted by the study drug
Participant has a preplanned surgery or procedure(s) that would interfere with the conduct of the study
Participant has received any prior treatment for IS
Participant has been previously treated with adrenocorticotropic hormone (ACTH), corticosteroids, or Vigabatrin for seizures;
Participant has been previously treated with a course of corticosteroids for an indication other than seizures within 30 days prior to Screening
Participant has a known or suspected allergy to ACTH or Vigabatrin or any component of AMZ002 or Vigabatrin
Participant has used any other investigational drug within 30 days or 5 half-lives prior to the first dose of AMZ002 or Vigabatrin (whichever is longer)
Participant' s parent/guardian is unable to provide written informed consent and/or to complete the daily diary
Participant has any other disease, condition, or therapy that, in the opinion of the Investigator, might compromise safety or compliance, preclude the participant from successfully completing the study, or interfere with the interpretation of the results

Intervenciones

drug

AMZ002 injectable solution, 0.5mg/mL

Injectable solution

drug

Vigabatrin, oral

Oral administration

Ubicaciones

Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Paediatric Hospital Dr. Juan P. Garrahan

Buenos Aires, Argentina

Patrocinadores

PrincipalAmzell

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