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NCT06690398 · ClinicalTrials.gov registry record · Phase 3
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
A Phase 3 study of Irritability Associated With Autism Spectrum Disorder, sponsored by Intra-Cellular Therapies.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 174
- Enrollment target
- 20
- Study locations
NCT06690398: Recruiting Phase 3 study of Irritability Associated With Autism Spectrum Disorder, sponsored by Intra-Cellular Therapies.
NCT06690398 is a Phase 3 study of Irritability Associated With Autism Spectrum Disorder that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 174 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06690398, a Phase 3 study of Irritability Associated With Autism Spectrum Disorder, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 174 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
The ABC-I subscale contains 15 items which rate symptoms on a scale ranging from 0 (not at all a problem) to 3 (severe).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lumateperone high dose
- DRUG Lumateperone low dose
Study Locations (20)
Florida
- Clinical Site - Gainesville
- Clinical Site - Jacksonville
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami Lakes
- Clinical Site - Miami Springs
- Clinical Site - West Palm Beach
California
- Clinical Site - Anaheim
- Clinical Site - Buena Park
- Clinical Site - Corona
- Clinical Site - Oceanside
- Clinical Site - Redlands
- Clinical Site - Upland
- Clinical Site - West Covina
Arizona
- Clinical Site - Peoria
- Clinical Site - Phoenix
Alabama
- Clinical Site - Dothan
Colorado
- Clinical Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 174 participants |
| Start Date | 2024-11-22 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
What NCT06690398 shows while recruiting
NCT06690398 is an interventional study that assigns participants to a tested intervention. The registered 174 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Irritability Associated With Autism Spectrum Disorder appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06690398 names 20 study sites across 5 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06690398 about?
NCT06690398 is a clinical study titled "Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients". 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-...
What is the current status of trial NCT06690398?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 174 participants. The study started on 2024-11-22. Estimated completion is 2027-04.
What conditions does trial NCT06690398 study?
This clinical trial studies the following conditions: Irritability Associated With Autism Spectrum Disorder.
What interventions are being tested in trial NCT06690398?
The interventions under investigation include: Placebo (DRUG), Lumateperone high dose (DRUG), Lumateperone low dose (DRUG).
Who is sponsoring clinical trial NCT06690398?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06690398 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Irritability Associated With Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06690398's enrollment target sits among peer trials
174 1443rd of 2000 higher than 556 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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