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Pediatric Open-Label Extension Study | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Pediatric Open-Label Extension Study

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

NCT01914393•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

6 - 17 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

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.

Locations (88)

Harmonex Neuroscience Research

Dothan, Alabama, United States

Diligent Clinical Trials, Inc

Downey, California, United States

University of California San Francisco Medical Center

San Francisco, California, United States

Neuropsychiatric Research Center of Orange County

Santa Ana, California, United States

Sarkis Clinical Trials - Parent

Gainesville, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

APG Research, LLC

Orlando, Florida, United States

Medical Research Group of Central Florida

Sanford, Florida, United States

University of South Florida

St. Petersburg, Florida, United States

University of South Florida Rothman Center of Neuropychiatry

Tampa, Florida, United States

Key Dates

Start Date

September 30, 2013

Primary Completion Date

October 17, 2018

Completion Date

October 17, 2018

Last Updated

December 19, 2019

Enrollment

702

ACTUAL participants

Conditions

SchizophreniaAutismBipolar Depression

Interventions

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

DRUG

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

NCT06290258

Autism Spectrum DisorderGastrointestinal Diseases+1 more

View study

RECRUITING

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

NCT00271622

Neurologic DisordersAutism+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pediatric Open-Label Extension Study

Inclusion Criteria

Exclusion Criteria

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

The Neurodevelopmental and Behavioral Phenotyping Screening Protocol

Enabling Parents of Children With Autism Spectrum Disorders - a Randomized Controlled Trial of Parenting Programs

Development of Prosocial Behaviors and Related Brain Network in Infants of High and Low Risk of ASD

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services