E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001064 |
E.1.2 | Term | Acute schizophrenia |
E.1.2 | System Organ Class | 100000004873 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 pediatric lurasidone study. |
|
E.2.2 | Secondary objectives of the trial |
•Proportions of subjects with adverse events (AEs), discontinuations due to AEs, and serious AEs (SAEs)
•Change in Positive and Negative Syndrome Scale (PANSS) total, positive, negative, general psychopathology, and excitability subscale scores
•Change in the Clinical Global Impression – Severity (CGI-S)
•PQ-LES-Q score
• Children’s Global Assessment Scale (CGAS) score
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects must provide written informed assent and be willing to participate in the study.
Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects’ adherence to the study procedures.
2. Male or female subjects 13 to 17 years of age
3. Subject has completed Study D1050301 (Visit 9), inclusive and all required assessments.
4. Willing and able to adhere to protocol-specified meal requirements during dosing.
5. Willing and able to swallow the size and number of lurasidone tablets specified per protocol.
|
|
E.4 | Principal exclusion criteria |
1. Subject is considered by the investigator to be at imminent risk of suicide.
2. Subject has evidence of any chronic organic disease of the CNS.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
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. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
•Proportions of subjects with adverse events (AEs), discontinuations due to AEs, and serious AEs (SAEs)
•Change in Positive and Negative Syndrome Scale (PANSS) total
•Change in the Clinical Global Impression – Severity (CGI-S)
•Change CDRS-R scores
•Change HAM-A at endpoint
•Change PQ-LES-Q score at endpoint
•Children’s Global Assessment Scale (CGAS) score
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
Bulgaria |
China |
Italy |
Romania |
Colombia |
Korea, Democratic People's Republic of |
Malaysia |
Puerto Rico |
Spain |
Philippines |
Serbia |
Ukraine |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |