Status:
COMPLETED
Pediatric Open-Label Extension Study
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Schizophrenia
Autism
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
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 pediat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 30 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2018
Estimated Enrollment :
702 Patients enrolled
Trial Details
Trial ID
NCT01914393
Start Date
September 30 2013
End Date
October 17 2018
Last Update
December 19 2019
Active Locations (88)
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1
Harmonex Neuroscience Research
Dothan, Alabama, United States, 36303
2
Diligent Clinical Trials, Inc
Downey, California, United States, 90241
3
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
4
Neuropsychiatric Research Center of Orange County
Santa Ana, California, United States, 92701