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NCT01914393 · ClinicalTrials.gov registry record · Phase 3
Pediatric Open-Label Extension Study
A Phase 3 study of Schizophrenia and Autism, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 702
- Enrollment target
- 20
- Study locations
NCT01914393: Completed Phase 3 study of Schizophrenia and Autism, sponsored by Sumitomo Pharma America.
NCT01914393 is a Phase 3 study of Schizophrenia and Autism that has completed, run by Sumitomo Pharma America. The registered enrollment target is 702 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (224% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01914393, a Phase 3 study of Schizophrenia and Autism, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 702 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
The Safety population consists of all subjects who received at least one dose of study drug in this study.
Conditions Studied
Interventions
- DRUG Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Study Locations (20)
Florida
- Sarkis Clinical Trials - Parent - Gainesville
- Clinical Neuroscience Solutions, Inc. - Orlando
- APG Research, LLC - Orlando
- Medical Research Group of Central Florida - Sanford
- University of South Florida - St. Petersburg
- University of South Florida Rothman Center of Neuropychiatry - Tampa
California
- Diligent Clinical Trials, Inc - Downey
- University of California San Francisco Medical Center - San Francisco
- Neuropsychiatric Research Center of Orange County - Santa Ana
Georgia
- Atlanta Center for Medical Research - Atlanta
- Attalla Consultants, LLC - Smyrna
Alabama
- Harmonex Neuroscience Research - Dothan
Kansas
- Psychiatric Associates - Overland Park
Kentucky
- University Of Kentucky - Lexington
Louisiana
- Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340 - Lake Charles
Maryland
- Kennedy Krieger Institute - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 702 participants |
| Start Date | 2013-09-30 |
| Est. Completion | 2018-10-17 |
| Phase | Phase 3 |
What the finished NCT01914393 record still lists
NCT01914393 is an interventional study that assigns participants to a tested intervention. The registered 702 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (224% higher).
The record links to 3 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Lurasidone 20, 40, 60, 80 mg, flexibly dosed is the first listed.
NCT01914393 names 20 study sites across 12 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01914393 about?
NCT01914393 is a clinical study titled "Pediatric Open-Label Extension Study". 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, D105...
What is the current status of trial NCT01914393?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 702 participants. The study started on 2013-09-30. Estimated completion is 2018-10-17.
What conditions does trial NCT01914393 study?
This clinical trial studies the following conditions: Schizophrenia, Autism, Bipolar Depression.
What interventions are being tested in trial NCT01914393?
The interventions under investigation include: Lurasidone 20, 40, 60, 80 mg, flexibly dosed (DRUG).
Who is sponsoring clinical trial NCT01914393?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01914393 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01914393's enrollment target sits among peer trials
702 19th of 315 higher than 297 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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