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

StatusRecruiting

PhasePhase 3

SponsorIntra-Cellular Therapies, Inc.

Started2024-11-22

View on ClinicalTrials.gov ↗

Amendment history

2026-08-27

Study Status, Contacts/Locations v7

Study sitesdetails revised at 2 of 35 sites

2026-07-30

Study Status, Contacts/Locations v6

Study sitesdetails revised at 2 of 35 sites

2026-07-22

Study Identification, Study Status, Contacts/Locations v5

Study sites34→35

2026-07-03

Study Status, Study Design, Contacts/Locations v4

Primary completion date2027-03→2027-06-21

Completion date2027-04→2027-07-19

Enrollment target174→160

Study sites37→34

2025-07-02

Study Status, Contacts/Locations v3

Study sites33→37

Show 2 earlier versions

2024-12-02

Study Status v2

Start dateestimated 2024-11→confirmed 2024-11-22

2024-11-20

Study Status, Study Description, Outcome Measures, Eligibility v1

Eligibility criteria+33 characters

Inclusion Criteria: All patients must have ana legally authorized representative LAR (eg, parent or legal guardian) who is willing and able [...]

2024-11-13

Original filing

Intra-Cellular Therapies, Inc.

18 trials monitored

See 3 trials at risk

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	NCT06690398
Lead Sponsor	Intra-Cellular Therapies, Inc.
Conditions	Irritability Associated With Autism Spectrum Disorder
Enrollment	160 participants
Start Date	2024-11-22
Primary Completion	2027-06-21 (estimated)
Study Completion	2027-07-19 (estimated)
Updated on ClinicalTrials.gov	2026-09-25