Pediatric Open-Label Extension Study

Completed · Phase 3

Conditions studied: Schizophrenia, Autism, Bipolar Depression

In brief

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

Key facts

Study ID

NCT01914393

Run by

Sumitomo Pharma America, Inc.

People needed

702

Starts

2013-09-30

Expected to finish

2018-10-17

Last updated by the study team

2019-12-19

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Attalla Consultants, LLC — Smyrna, Georgia, United States
• Psychiatric Associates — Overland Park, Kansas, United States
• University Of Kentucky — Lexington, Kentucky, United States
• Lake Charles Clinical Trials LLC,2770 3rd Avenue,Suite 340 — Lake Charles, Louisiana, United States
• Kennedy Krieger Institute — Baltimore, Maryland, United States
• Neurobehavioral medicine Group, LLC — Bloomfield Hills, Michigan, United States
• St. Charles Psychiatric Associates — Saint Charles, Missouri, United States
• Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• North Shore/Long Island Jewish PRIME — Glen Oaks, New York, United States
• Dr. Jeanette Cueva — Mount Kisco, New York, United States
• Montefiore Medical Center PRIME — New York, New York, United States
• Finger Lakes Clinical Research — Rochester, New York, United States
• Richmond Behavioral Associates — Staten Island, New York, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• Harmonex Neuroscience Research — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

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