Schizophrenia MedDRA version: 21.1 Level: LLT Classification code 10001064 Term: Acute schizophrenia System Organ Class: 100000004873 MedDRA version: 20.0 Level: LLT Classification code 10008525 Term: Childhood schizophrenia System Organ Class: 100000004873
Conditions
Sponsors
Sunovion Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject has completed the Treatment Period of Study SEP361-301 or Study SEP361-302. • Subject has not taken any medication other than the study drug and protocol-allowed medications for the purpose of controlling schizophrenia symptoms during Study SEP361-301 or SEP361-302. Are the trial subjects under 18? yes Number of subjects for this age range: 57 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 555 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Subject answered “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 assessment at the EOT Visit of Study SEP361-301 or SEP361-302. • Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at the EOT Visit of Study SEP361-301 or SEP361-302 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety and tolerability of flexibly dosed SEP-363856 (25, 50, 75, 100 mg/day) in subjects with schizophrenia who have completed Studies SEP361-301 and SEP361-302 by the incidence of overall adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.;Secondary Objective: • To evaluate the long-term safety and tolerability of SEP-363856 by assessing: o physical examinations (PE). o 12-lead electrocardiograms (ECG). o vital sign measurements. o clinical laboratory tests. o Columbia – Suicide Severity Rating Scale (C-SSRS). o Simpson-Angus Scale (SAS). o Barnes Akathisia Rating Scale (BARS). o Abnormal Involuntary Movement Scale (AIMS).;Primary end point(s): The incidence of overall AEs, SAEs, and AEs leading to discontinuation.;Timepoint(s) of evaluation of this end point: From the time of the first dose of study drug through 9 days following the last dose of the open-label extension study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Observed values and changes from double-blind (DB) Baseline of Study SEP361-301 or SEP361-302 and from open-label (OL) Baseline of Study SEP361-303 in clinical laboratory tests (including hematology, chemistry and urinalysis). • Observed values and changes from DB Baseline of Study SEP361-301 or SEP361-302 and from OL Baseline of Study SEP361-303 in vital signs (including temperature, body weight, height (as measured by a stadiometer for adolescents), BMI, waist circumference, blood pressure [supine and standing], pulse rate [supine and standing] and respiratory rate) and 12-lead ECG parameters. • Frequency and severity of suicidal ideation and suicidal behavior based on the C-SSRS. • Observed values and changes from DB Baseline of Study SEP361-301 or SEP361-302, and from OL Baseline of Study SEP361-303, in SAS, BARS and AIMS scores.;Timepoint(s) of evaluation of this end point: Changes from Baseline will be summarized at each scheduled post-OL Baseline extension visit through Week 52. | — |
Countries
Bulgaria, Colombia, Croatia, Latvia, Russian Federation, Serbia, Ukraine, United States
Contacts
Public ContactMedical Director
IQVIA
Outcome results
None listed