NCT06229210

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

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Intra-Cellular Therapies, Inc. · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study will enroll pediatric patients as follows: De Novo Patients: * Patients with schizophrenia, including patients who have previously participated in the lumateperone open-label pediatric pharmacokinetic (PK) study (Study ITI-007-020) * Patients with bipolar disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-030) * Patients with irritability associated with autism spectrum disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-035) Rollover Patients: * Patients with bipolar disorder who are enrolling directly from a lead-in efficacy study. * Patients with irritability associated with autism spectrum disorder who are enrolling directly from a lead-in efficacy study. This study will be conducted as follows: * A Screening Period of up to 2 weeks during which patient eligibility will be assessed. * A 26-week Open-label Treatment Period (OLTP) during which all patients will receive open-label lumateperone once daily. * A 2-week Safety Follow-up (SFU) Period: All patients should return to the clinic for the SFU visit approximately 2 weeks after the last dose of open-label lumateperone.

Conditions

• Schizophrenia
• Bipolar Disorder
• Autism Spectrum Disorder

Interventions

Type	Name	Description
DRUG	Lumateperone	Lumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication

Timeline

• Start date: 2024-01-25
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-01-29
• Last updated: 2025-07-08

Locations

50 sites across 2 countries: United States, Serbia

Regulatory

• FDA-regulated drug study