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NCT06229210 · ClinicalTrials.gov registry record · Phase 3
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
A Phase 3 study of Schizophrenia and Autism Spectrum Disorder, sponsored by Intra-Cellular Therapies.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT06229210 is a Phase 3 study of Schizophrenia and Autism Spectrum Disorder that is actively recruiting participants, run by Intra-Cellular Therapies. The registered enrollment target is 500 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (130% higher). The trial reports 20 study locations across 5 states.
The verdict
NCT06229210, a Phase 3 study of Schizophrenia and Autism Spectrum Disorder, is actively recruiting participants, sponsored by Intra-Cellular Therapies.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
Conditions Studied
Interventions
- DRUG Lumateperone
Study Locations (20)
Florida
- Clinical Site - Gainesville
- Clinical Site - Hialeah
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami
- Clinical Site - Miami Gardens
California
- Clinical Site - Anaheim
- Clinical Site - Colton
- Clinical Site - Garden Grove
- Clinical Site - Long Beach
- Clinical Site - Redlands
- Clinical Site - San Diego
- Clinical Site - West Covina
Arizona
- Clinical Site - Phoenix
Arkansas
- Clinical Site - Little Rock
Colorado
- Clinical Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-01-25 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06229210
The ClinicalTrials.gov registry entry for NCT06229210 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (130% higher). The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Lumateperone is the first listed.
NCT06229210 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT06229210 about?
NCT06229210 is a clinical study titled "Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder". This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.
What is the current status of trial NCT06229210?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2024-01-25. Estimated completion is 2027-12.
What conditions does trial NCT06229210 study?
This clinical trial studies the following conditions: Schizophrenia, Autism Spectrum Disorder, Bipolar Disorder.
What interventions are being tested in trial NCT06229210?
The interventions under investigation include: Lumateperone (DRUG).
Who is sponsoring clinical trial NCT06229210?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06229210 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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