Extension study for the D1050301 Adolescent Schizophrenia study, the D1050325 Children and Adolescent autistic disorder and the D1050326 Children and Adolescent Bioplar I Depression MedDRA version: 20.0 Level: LLT Classification code 10004936 Term: Bipolar depression System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 20.0 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders MedDRA ver
Conditions
Interventions
Trade Name: LATUDA
Product Name: LURASIDONE
Product Code: SM-13496
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lurasidone Hydrochloride
CAS Number: 367514-88-3
Other descriptive name:
Sponsors
SUNOVION PHARMACEUTICALS INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. Subject has completed Study D1050301 or 325 (Visit 9); OR Subject has completed Study D1050326 (Visit 8). 3. 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. 4. 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. 5. 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. 6. 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 Are the trial subjects under 18? yes Number of subjects for this age range: 702 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subject is considered by the investigator to be at imminent risk of suicide. 2. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety, tolerability, and effectiveness of lurasidone (20, 40, 60 or 80 mg/day, flexibly dosed) in pediatric subjects who have completed a prior lurasidone study.;Secondary Objective: • Proportions of subjects with adverse events (AEs), discontinuations due to AEs, and serious AEs (SAEs). Subjects from D1050301: • Change in Positive and Negative Syndrome, general psychopathology, and excitability; in the Clinical Global Impression; in the Clinician-rated Children’s Global Assessment Scale; in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire. Subjects from D1050325: • Change in Aberrant Behavior;in the Clinical Global Impression – Severity; in Children's Yale-Brown Obsessive Compulsive Scales modified for pervasive developmental disorders; in the Caregiver Strain Questionnaire. Subjects from D1050326: • Change in the Children's Depression Rating Scale, the Clinical Global Impression Bipolar Version ; in the Clinician-rated Children’s Global Assessment Scale; in the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire; in anxiety symptoms as measured by the Pediatric Anxiety Rating Scale; in attention-deficit/hyperactivity ;Primary end point(s): 6.1. Safety Assessments All Subjects: • Treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and serious AEs (SAEs); • Laboratory tests, vital signs, body weight and body mass index (BMI), waist circumference, physical examination, height (as measured by stadiometer), electrocardiogram (ECG), hormonal parameters; • Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS); • Tanner staging, and menstrual cyclicity (female subjects). For subjects continued from Study D1050301 and D1050326: • Columbia Suicide Severity Rating Scale (C-SSRS); • Composite Score of the CogState Computerized Cognitive Test Battery; • Udvalg for Kliniske Underso | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): see all listed under E.5.1 above;Timepoint(s) of evaluation of this end point: throughout the study | — |
Countries
Belgium, Bulgaria, China, Colombia, Croatia, France, Germany, Hungary, Italy, Korea, Republic of, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Romania, Russian Federation, Serbia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactJustine Kent
Sunovion Pharmaceuticals Inc.
Outcome results
None listed