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Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients

StatusRecruiting
PhasePhase 3
Started2024-12-06
View on ClinicalTrials.gov ↗

Amendment history

2026-08-27
Study Status, Contacts/Locations v6
Study sitesdetails revised at 2 of 40 sites
2026-07-30
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 40 sites
2026-07-22
Study Identification, Study Status, Contacts/Locations v4
Study sites38→40
2026-07-02
Study Status, Study Design, Contacts/Locations v3
Primary completion date2027-03→2027-06-21
Completion date2027-04→2027-06-21
Enrollment target174→160
Study sites39→38
2025-07-03
Study Status, Contacts/Locations v2
Study sites40→39
2025-01-24
Study Status v1
Start dateestimated 2024-11→confirmed 2024-12-06
2024-11-22
Original filing
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).
Trial Details
NCT Number NCT06706674
Lead Sponsor Intra-Cellular Therapies, Inc.
Conditions Irritability Associated With Autism Spectrum Disorder
Enrollment 160 participants
Start Date 2024-12-06
Primary Completion 2027-06-21 (estimated)
Study Completion 2027-06-21 (estimated)
Updated on ClinicalTrials.gov 2026-09-25