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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06690398

Public ClinicalTrials.gov record NCT06690398. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Jul 22, 2026, 1:50 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

Study identification

NCT ID
NCT06690398
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Intra-Cellular Therapies, Inc.
Industry
Enrollment
160 participants

Conditions and interventions

Interventions

  • Lumateperone high dose Drug
  • Lumateperone low dose Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
5 Years to 17 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 21, 2024
Primary completion
Jun 20, 2027
Completion
Jul 18, 2027
Last update posted
Jul 6, 2026

2024 – 2027

United States locations

U.S. sites
34
U.S. states
15
U.S. cities
30
Facility City State ZIP Site status
Harmonex Neuroscience Research Dothan Alabama 36303 Recruiting
Southwest Autism Research and Resource Center Phoenix Arizona 85006 Recruiting
Advanced Research Center Inc Anaheim California 92805 Recruiting
Excell Research Inc Oceanside California 92056 Recruiting
Inland Psychiatric Medical Group Inc Redlands California 92373 Recruiting
Buena Park Research Upland California 91786 Completed
Next Level Clinical Trials, LLC West Covina California 91790 Recruiting
MCB Clinical Research Centers LLC Colorado Springs Colorado 80910 Completed
Royal Palm Clinical Research Fort Myers Florida 33901 Suspended
Sarkis Clinical Trials Gainesville Florida 32607 Recruiting
Green Leaf Clinical Trials Jacksonville Florida 32258 Recruiting
Columbus Clinical Services LLC Miami Florida 33125 Suspended
South Florida Research Phase I-IV Miami Florida 33166 Recruiting
Diverse Clinical Research LLC Miami Florida 33175 Recruiting
Anchor Medical Research LLC Miami Florida 33176 Recruiting
Links Clinical Trials Miami Florida 33176 Recruiting
The Angel Medical Research Corporation Miami Gardens Florida 33169 Recruiting
Health Synergy Clinical Research West Palm Beach Florida 33407 Recruiting
CenExeli Research LLC Savannah Georgia 31405 Recruiting
Revive Research Institute Elgin Illinois 60123 Recruiting
Southern Illinois University School of Medicine Springfield Illinois 62701 Suspended
Massachusetts General Hospital Boston Massachusetts 02114 Completed
Midwest Research Group Saint Charles Missouri 63304 Recruiting
Vector Clinical Trials Las Vegas Nevada 89128 Recruiting
Charak Center for Health and Wellness Garfield Ohio 44125 Recruiting
Westlake Brain Health Westlake Ohio 44145 Completed
Access Clinical Trials Nashville Tennessee 37203 Recruiting
REX Clinical Trials LLC Beaumont Texas 77701 Recruiting
North Pointe Psychiatry Flower Mound Texas 76028 Recruiting
Kaleidoscope Clinical Research Houston Texas 77089 Recruiting
AIM Trials Plano Texas 75093 Recruiting
Perceptive Pharma Research Richmond Texas 77407 Recruiting
Clinical Research Partners, LLC Petersburg Virginia 23805 Recruiting
Northwest Clinical Research Center Bellevue Washington 98007 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06690398, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 6, 2026 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06690398 live on ClinicalTrials.gov.

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