Schizophrenia MedDRA version: 20.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Latuda
Product Name: Lurasidone
Product Code: SM-13496
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lurasido
Sponsors
Sunovion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must be fully informed of and understand the objectives, procedures, and possible benefits and risks of the study, and give written informed consent prior to performing any study-related activities. If the subject is considered a minor per local regulations at the time of collection of the informed consent, written consent will be obtained from a legally acceptable representative (guardian) in addition to that obtained from the subject. 2. Subject has completed the 6-week double-blind phase of study D1001066 and has completed all required assessments on the final study visit. 3. Subject is judged to be suitable for participation in a 12-week clinical study involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator. 4. Female subjects must not be pregnant (must have a negative urine pregnancy test at Visit 1E [Study Visit Number 9 in Study D1001066]) nor nursing (must not be lactating) and not planning to become pregnant within the projected duration of the study. 5. Female subjects who are of childbearing potential and male subjects whose partners are of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and for at least 7 days after the last dose of study drug has been taken. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 273 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Subject is considered by the Investigator to be at imminent risk of suicide or injury to self or others, or subject answers “yes” to “Suicidal Ideation” item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS at Visit 1E (Study Visit Number 9 in Study D1001066). Subjects who answer “yes” to this question must be referred by the Investigator for appropriate follow-up evaluation and treatment. 2. Subject exhibits evidence of severe tardive dyskinesia, severe dystonia, or any other severe movement disorder. Severity is to be determined by the Investigator. 3. Subject requires treatment with any potent CYP3A4 inhibitors or inducers during the study. 4. Subject is otherwise considered ineligible for the study by the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the long-term safety of lurasidone (40 and 80 mg/day) in subjects with schizophrenia who have completed participation in Study D1001066.;Secondary Objective: The secondary objective is to evaluate the long-term effectiveness of lurasidone (40 and 80 mg/day) in subjects with schizophrenia who have completed participation in Study D1001066.;Timepoint(s) of evaluation of this end point: Various time points throughout the study; Primary end point(s): Safety Endpoint • Frequency of adverse events (AEs) or treatment-related AEs, extrapyramidal AEs, SAEs, and AEs leading to study discontinuation; • Absolute values and changes from Open-label and Double-blind Baseline in: - Laboratory test values including: measures of glycemic control and lipids; - Vital signs; - Body weight, waist circumference, and body mass index (BMI); - Electrocardiogram (ECG) parameters including corrected QT (QTc) interval. • Proportions of subjects using concomitant antiparkinsonian drugs; • Change from Open-label and Double-blind Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) total score (excluding the overall severity) at each post-baseline visit; • Frequency of subjects with suicidal behaviour and suicidal ideation measured by Columbia-Suicide Severity Rating Scale (C-SSRS). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Endpoint • Change from Open-label and Double-blind Baseline in Positive and Negative Syndrome Scale (PANSS) total score at each post-baseline visit; • Change from Open-label and Double-blind Baseline in Clinical Global Impression-Severity Scale (CGI-S) score at each post-baseline visit; • Change from Open-label and Double-blind Baseline in PANSS subscale scores at each post-baseline visit; • Change from Open-label and Double-blind Baseline in PANSS five-factor model scores at each post-baseline visit. The PANSS five-factor model is defined as follows: - Negative symptoms: Blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of spontaneity and flow of conversation, and active social avoidance; - Excitement: Excitement, hostility, tension, and poor impulse control; - Cognitive disorders: Conceptual disorganization, difficulty in abstract thinking, mannerisms and posturing, disorientation, and poor attention; - Positive symptoms: Delusions, grandiosity, suspiciousness/persecution, and unusual thought content; - Anxiety/depression: Somatic concern, anxiety, guilt feelings, depression, and preoccupation. • Change from Open-label and Double-blind Baseline in Calgary Depression Scale for Schizophrenia (CDSS) total scores at each post-baseline visit. • Time to all-cause discontinuation from Open-label Baseline. Other Endpoint • Change from Open-label and Double-blind Baseline in Euroqol-5 Dimensions-3 Levels (EQ-5D-3L) index score at Week 12. ;Timepoint(s) of evaluation of this end point: Various time points throughout the study | — |
Countries
India, Japan, Poland, Romania, Russian Federation, Slovakia, Ukraine
Contacts
Public ContactRobert S Goldman
Sunovion Pharmaceuticals Inc.
Outcome results
None listed