A 104-Week, Flexible-Dose, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Effectiveness of Lurasidone in Pediatric Subjects

Sumitomo Pharma America, Inc.88 sites in 7 countries702 target enrollmentSeptember 30, 2013

ConditionsSchizophrenia Autism Bipolar Depression

InterventionsLurasidone 20, 40, 60, 80 mg, flexibly dosed

DrugsLurasidone 20, 40, 60, 80 mg, flexibly dosed

Overview

Phase: Phase 3
Intervention: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Conditions: Schizophrenia
Sponsor: Sumitomo Pharma America, Inc.
Enrollment: 702
Locations: 88
Primary Endpoint: Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

September 30, 2013

End Date

October 17, 2018

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sumitomo Pharma America, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' participation in the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
•Subject has completed Study D1050301 (Visit 9) OR
•Subject has completed Study D1050325 (Visit 9) OR
•Subject has completed Study D1050326 (Visit 8)
•Subject is judged by the investigator to be appropriate for participation in a 104-week clinical trial in an outpatient setting involving open-label lurasidone treatment, and is able to comply with the protocol.
•A reliable informant (eg, parent, legal guardian, or caregiver) must be available to accompany the subject at each visit. For subjects entering from Study D1050325, the reliable caregiver must also oversee the administration of the study drug throughout the study
•Females who participate in this study:
•are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-
•practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR-
•are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.

Exclusion Criteria

•Subject is considered by the investigator to be at imminent risk of suicide.
•Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.

Arms & Interventions

Lurasidone 20, 40, 60, 80 mg, flexibly dosed

Lurasidone 20, 40, 60, 80 mg, flexibly dosed, once daily

Intervention: Lurasidone 20, 40, 60, 80 mg, flexibly dosed

Outcomes

Primary Outcomes

Number of Subjects With Adverse Events (AEs), Discontinuations Due to AEs and Serious AEs (SAEs)

Time Frame: During 104 Weeks (2-years) treatment period

The Safety population consists of all subjects who received at least one dose of study drug in this study.

Secondary Outcomes

Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in PANSS Positive Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in PANSS Negative Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in PANSS General Psychopathology Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in PANSS Excitability Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Percentage Maximum Possible Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Aberrant Behavior Checklist (ABC) Hyperactivity and Noncompliance Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Children's Depression Rating Scale, Revised (CDRS-R) Total Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in the Clinical Global Impression -Severity Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Aberrant Behavior Checklist (ABC) Stereotypic Behavior Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Clinician-Rated Children's Global Assessment Score (CGAS) Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Pediatric Anxiety Rating Scale (PAR) Total Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Aberrant Behavior Checklist (ABC) Irritability Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Aberrant Behavior Checklist (ABC) Inappropriate Speech Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Children's Yale-Brown Obsessive Compulsive Score (CY-BOCS)(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Clinical Global Impression Bipolar Version (CGI-BP-S) Depression Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Aberrant Behavior Checklist (ABC) Lethargy and Social Withdrawal Subscale Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Clinical Global Impression (CGI) - Severity Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Caregiver Strain Questionnaire (CGSQ) Global Strain Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) Score(Open-Label Baseline, Week 28, Week 52, and Week 104)
Change From Baseline in Attention-Deficity/Hyperactivity Disorder Rating Scale (ADHD-RS) Total Score(Open-Label Baseline, Week 28, Week 52, and Week 104)