At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 702 enrolled
Drug / intervention
Lurasidone 20, 40, 60, 80 mg, flexibly doseddrug
Likely dose
Lurasidone 20, 40, 60, 80 mg, flexibly dosedfrom 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.
A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects
In Brief
A Phase 3 clinical trial evaluating Lurasidone 20, 40, 60, 80 mg, flexibly dosed for Schizophrenia and 2 related conditions. Completed, enrolled 702 participants across 88 sites in 15 countries.
Detailed Summary
This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Autism, Bipolar Depression
CountriesBulgaria, Colombia, France, Hungary, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Romania, Russia, South Korea, Spain, Ukraine, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 2013
Enrollment StartSep 2013
Primary CompletionOct 2018
TodayJul 2026
First PostedAug 2, 2013
Enrollment StartSep 30, 2013
Primary CompletionOct 17, 2018
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 12.9 years ago
Interventions
Lurasidone 20, 40, 60, 80 mg, flexibly doseddrug
Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed