At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 26 enrolled
Drug / intervention
Lumateperone 42 mg +1 moredrug
Likely dose
Lumateperone 42 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Multiple Oral Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lumateperone in Patients, Ages 13 to 17 Years, Diagnosed With Schizophrenia or Schizoaffective Disorder
In Brief
A Phase 1 clinical trial evaluating Lumateperone 42 mg and Lumateperone 28 mg for Schizophrenia and Pediatric. Completed, enrolled 26 participants across 3 sites.
Detailed Summary
Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Pediatric
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
First PostedMar 2021
Enrollment StartMar 2021
Primary CompletionJul 2022
TodayJul 2026
First PostedMar 3, 2021
Enrollment StartMar 12, 2021
Primary CompletionJul 30, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.3 years ago
Interventions
Lumateperone 42 mgdrug
Lumateperone 42 mg, oral administration
Lumateperone 28 mgdrug
Lumateperone 28 mg, oral administration