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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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06690398
The ClinicalTrials.gov registry entry for NCT06690398 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 174 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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