Estudio multicéntrico de lumateperona para el tratamiento de la irritabilidad asociada con el trastorno del espectro autista en pacientes pediátricos
Un estudio multicéntrico, aleatorizado, doble ciego, controladora con placebo para evaluar la eficacia y seguridad de la lumateperona en el tratamiento de la irritabilidad asociada con el trastorno del espectro autista en pacientes pediátricos de 5 a 17 años
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) and confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia Present and Lifetime Version (K-SADS-PL).
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The study will be conducted in 3 phases:
- Screening Period (up to 14 days) during which patient eligibility will be assessed.
- Double-blind Treatment Period (DBTP) (6 weeks) during which all patients will be randomized in a 1:1:1 ratio to receive either lumateperone high dose, lumateperone low dose, or placebo as a once daily dose.
- Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up (SFU) visit approximately 1 week after the last dose of study drug.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Study Contact
- Número de teléfono: 844-434-4210
- Correo electrónico: Participate-In-This-Study1@its.jnj.com
Ubicaciones de estudio
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Alabama
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Dothan, Alabama, Estados Unidos, 36303
- Reclutamiento
- Harmonex Neuroscience Research
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Arizona
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Phoenix, Arizona, Estados Unidos, 85006
- Reclutamiento
- Southwest Autism Research and Resource Center
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California
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Anaheim, California, Estados Unidos, 92805
- Reclutamiento
- Advanced Research Center Inc
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Oceanside, California, Estados Unidos, 92056
- Reclutamiento
- Excell Research Inc
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Redlands, California, Estados Unidos, 92373
- Reclutamiento
- Inland Psychiatric Medical Group Inc
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Upland, California, Estados Unidos, 91786
- Terminado
- Buena Park Research
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West Covina, California, Estados Unidos, 91790
- Reclutamiento
- Next Level Clinical Trials, LLC
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80910
- Terminado
- MCB Clinical Research Centers LLC
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Florida
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Fort Myers, Florida, Estados Unidos, 33901
- Suspendido
- Royal Palm Clinical Research
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Gainesville, Florida, Estados Unidos, 32607
- Reclutamiento
- Sarkis Clinical Trials
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Jacksonville, Florida, Estados Unidos, 32258
- Reclutamiento
- Green Leaf Clinical Trials
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Miami, Florida, Estados Unidos, 33176
- Reclutamiento
- Anchor Medical Research LLC
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Miami, Florida, Estados Unidos, 33176
- Reclutamiento
- Links Clinical Trials
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Miami, Florida, Estados Unidos, 33125
- Reclutamiento
- Columbus Clinical Services LLC
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Miami, Florida, Estados Unidos, 33175
- Reclutamiento
- Diverse Clinical Research LLC
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Miami, Florida, Estados Unidos, 33166
- Reclutamiento
- South Florida Research Phase I-IV
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Miami Gardens, Florida, Estados Unidos, 33169
- Reclutamiento
- The Angel Medical Research Corporation
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West Palm Beach, Florida, Estados Unidos, 33407
- Reclutamiento
- Health Synergy Clinical Research
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Georgia
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Savannah, Georgia, Estados Unidos, 31405
- Reclutamiento
- CenExeli Research LLC
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Illinois
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Elgin, Illinois, Estados Unidos, 60123
- Reclutamiento
- Revive Research Institute
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Springfield, Illinois, Estados Unidos, 62701
- Suspendido
- Southern Illinois University School of Medicine
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Terminado
- Massachusetts General Hospital
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Worcester, Massachusetts, Estados Unidos, 01655
- Reclutamiento
- UMass Memorial Healthcare
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Missouri
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Saint Charles, Missouri, Estados Unidos, 63304
- Reclutamiento
- Midwest Research Group
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89128
- Reclutamiento
- Vector Clinical Trials
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Ohio
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Garfield, Ohio, Estados Unidos, 44125
- Reclutamiento
- Charak Center for Health and Wellness
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Westlake, Ohio, Estados Unidos, 44145
- Terminado
- Westlake Brain Health
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- Access Clinical Trials
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Texas
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Beaumont, Texas, Estados Unidos, 77701
- Reclutamiento
- REX Clinical Trials LLC
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Flower Mound, Texas, Estados Unidos, 76028
- Terminado
- North Pointe Psychiatry
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Houston, Texas, Estados Unidos, 77089
- Reclutamiento
- Kaleidoscope Clinical Research
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Plano, Texas, Estados Unidos, 75093
- Reclutamiento
- AIM Trials
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Richmond, Texas, Estados Unidos, 77407
- Reclutamiento
- Perceptive Pharma Research
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Virginia
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Petersburg, Virginia, Estados Unidos, 23805
- Reclutamiento
- Clinical Research Partners, LLC
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Washington
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Bellevue, Washington, Estados Unidos, 98007
- Reclutamiento
- Northwest Clinical Research Center
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Belgrade, Serbia, 11000
- Reclutamiento
- Institute of Mental Health Serbia
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Belgrade, Serbia, 11000
- Reclutamiento
- Institute of Mental Health Serbia 1
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Belgrade, Serbia, 11070
- Reclutamiento
- Clinic of Neurology and Psychiatry for Children and Youth
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Niš, Serbia, 18000
- Reclutamiento
- University Clinical Center NIS
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
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All patients must have a legally authorized representative LAR (eg, parent or legal guardian) who is willing and able to be responsible for the safety and well-being of the patient, provide information about the patient's condition, and accompany the patient to study visits.
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Able to provide consent as follows:
- The patient's LAR must provide written, informed consent.
- When developmentally appropriate based on Investigator judgment, the patient should provide written assent.
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Male or female patients 5 to 17 years of age. Currently, only patients aged 13 to 17 years will be eligible for enrollment.
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Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of ASD as confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);
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ABC-I subscale score of >18 at Screening and Baseline;
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CGI-S score > 4 with respect to irritability associated with ASD at Screening and Baseline.
Exclusion Criteria:
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Has a primary psychiatric diagnosis other than ASD. Exceptions include:
- Attention Deficit Hyperactivity Disorder (ADHD). If a patient is taking medication(s) for ADHD, they must be on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.
- Mild and moderate intellectual disability based on Investigator judgment and DSM-5 criteria (severe and profound intellectual disability are excluded).
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History or current diagnosis of Rett syndrome or Fragile X syndrome;
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In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or
- At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
- The patient is considered to be an imminent danger to themselves or others.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
Placebo |
Matching Placebo administered orally once daily |
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Experimental: Lumateperone high dose
Lumateperone 42 mg for patients ages 13-17 years old |
Lumateperone administered orally once daily |
|
Experimental: Lumateperone low dose
Lumateperone 21 mg for patients ages 13-17 years old |
Lumateperone administered orally once daily |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Aberrant Behavior Checklist - Irritability (ABC-I)
Periodo de tiempo: Week 6
|
The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe). |
Week 6
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinical Global Impression-Severity (CGI-S)
Periodo de tiempo: Week 6
|
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). |
Week 6
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ITI-007-601
- ITI-007-601 (Otro identificador: Janssen Research & Development, LLC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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