A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

April 30, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Spasms, Infantile
Interventions
DRUG

AMZ002 injectable solution, 0.5mg/mL

Injectable solution

DRUG

Vigabatrin, oral

Oral administration

Trial Locations (41)

8041

Hospital de la Santa Creu i Sant Pau, Barcelona

10305

Staten Island University Hospital, North, Staten Island

27157

Wake Forest Baptist Medical Center - PPDS, Winston-Salem

30329

Childrens Healthcare of Atlanta, Atlanta

32803

Advent Health Orlando, Orlando

32806

Arnold Palmer Hospital For Children, Orlando

33076

CHU Bordeaux - Hopital des Enfants, Bordeaux

33155

Miami Children's Hospital, Miami

40536

University of Kentucky Hospital, Lexington

60611

Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago

66278

Tecnologico De Monterrey - Hospital Zambrano Hellion - Instituto de Neurologia y Neurocirugia, Nuevo León

69500

HFME-Hospices Civils de Lyon, Bron

75207

UT Southwestern Medical Center, Dallas

110029

All India Institute of Medical Sciences, New Delhi

411043

Bharati Vidyapeeth Deemed University - Bharati Hospital, Pune

560029

Indira Gandhi Institute of Child Health, Bangalore

682041

Amrita Advanced Centre for Epilepsy, Kochi

80045-7106

The Childrens Hospital Colorado, Aurora

02420

Children's Brain Institute, Lexington

48201-2119

Children's Hospital of Michigan, Detroit

Unknown

Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia, Buenos Aires

Hospital Italiano de Buenos Aires, Buenos Aires

Paediatric Hospital Dr. Juan P. Garrahan, Buenos Aires

Hopital Roger Salengro - CHU de Lille, Lille

Hopital Necker - Enfants Malades, Paris

Hopital de Hautepierre, Strasbourg

Azienda Ospedaliero Universitaria, Ancona

Pediatric Hospital G. Salesi, Ancona

AOU Anna Meyer - Clinica di Neurologia Pediatrica, Florence

Istituto Pediatrico Giannina Gaslini, Genova

Ospedale dei Bambini Vittore Buzzi, Milan

Universita degli Studi di Napoli Federico II, Naples

Ospedale Pediatrico Bambino Gesu, Roma

Policlinico Universitario A.Gemelli, Roma

Azienda Ospedaliera Universitaria Integrata, Verona

Neurociencias Estudios Clinicos S.C., Culiacán

HSRT, Mexico City

The University Clinical Center, Gdansk

Provincial Specialist Children's Hospital st. Ludwika, Krakow

Institute of Mother and Child, Warsaw

02-091

Medical University of Warsaw, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amzell

INDUSTRY

NCT05128344 - A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms | Biotech Hunter | Biotech Hunter