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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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01914393
The ClinicalTrials.gov registry entry for NCT01914393 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 702 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (224% higher). The listed sponsor is Sumitomo Pharma America, which has 168 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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Related
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