Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Intra-Cellular Therapies, Inc.
- Study ID
- NCT06229210
- Phase
- PHASE3
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- Lumateperone — DRUGLumateperone 5 mg - 42 mg capsules or orally disintegrating tablets administered orally, once daily based on age and indication
Study Details
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.
Key Dates
- First listed
- Jan 29, 2024
- Start date
- Jan 25, 2024
- Status verified
- Jul 2026
- Primary completion
- Apr 28, 2032
- Completion
- Apr 28, 2032
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Lumateperone
Primary Outcome Measure
Incidence of Common Adverse Events [ Time Frame: Up to 6 months ]
Central Contacts
- ITI Clinical Trials646 440-9333
Locations (57)
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