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Lurasidone long-term extension in pediatric subjects
NCT01914393Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2013
- Primary completion
- Oct 2018
- Countries
- 15
- Sponsor
- Sumitomo Pharma America
- Modality
- Small Molecules
- Drugs
- lurasidone
- Conditions
- schizophreniabipolar disorder (BD)Autism Spectrum Disorder (ASD)
01
Overview
Phase 3, open-label, single-arm trial of lurasidone in schizophrenia, bipolar disorder (BD) and Autism Spectrum Disorder (ASD), sponsored by Sumitomo Pharma America. Primary endpoint: Number of Subjects With Adverse Events, Discontinuations Due to AEs and Serious AEs at 104 weeks. Started Sep 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Lurasidone Flexible Dose
Lurasidone 20, 40, 60, 80 mg/day, flexibly dosed
03
Who it enrols
Pediatric subjects who have completed the 6-week treatment period in the preceding studies D1050301 (Schizophrenia), D1050325 (Autism), or D1050326 (Bipolar Depression) and are judged appropriate for outpatient open-label treatment.
04
Endpoints
Primary
Number of Subjects With Adverse Events, Discontinuations Due to AEs and Serious AEs
Secondary
Positive and Negative Syndrome Scale Total Score
PANSS Positive, Negative, General Psychopathology, and Excitability Subscale Scores
Clinical Global Impression - Severity Score
Clinician-Rated Children's Global Assessment Scale Score
Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire Percentage Maximum Possible Score
Aberrant Behavior Checklist Irritability Subscale Score
Aberrant Behavior Checklist Lethargy/Social Withdrawal, Stereotypic Behavior, Hyperactivity/Noncompliance, Inappropriate Speech Subscale Scores
Children's Yale-Brown Obsessive Compulsive Score
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