drugset / Trial / NCT06229210

Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

NCT06229210

Phase 3 Recruiting 300 enrolled Intra-Cellular Therapies, Inc.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-01-25
Primary completion
2032-04-28
Completion
2032-04-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Lumateperone Small molecule 5 mg Oral
Subject Lumateperone Small molecule 42 mg Oral