Schizophrenia MedDRA version: 19.0 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Code: SEP-363856
Pharmaceutical Form: Capsule
Current Sponsor code: SEP-363856-01
Concentration unit: mg milligram(s)
Concentrat
Sponsors
SUNOVION PHARMACEUTICALS INC.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To qualify for participation, subjects must meet all of the following inclusion criteria: 1.Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator. 2.Subject has completed Study SEP361 201 through Week 4. 3.Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201. 4.Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test. 5.Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration. 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 180 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To qualify for participation, subjects must not meet any of the following exclusion criteria: 1.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 assessment at Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation. 2.Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study. 3.Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of Study SEP361 201. 4.Subject is pregnant or lactating. 5.Subject is at high risk of non-compliance in the Investigator's opinion. 6.Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the long-term safety and tolerability of flexibly dosed SEP 363856 (25, 50, or 75 mg/day [ie, once daily]) in adult subjects with schizophrenia who have completed Study SEP361 201 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 vital signs, physical examinations (PE), body weight and body mass index (BMI), 12 lead electrocardiograms (ECG), clinical laboratory evaluations, and suicidal ideation and suicidal behavior using the Columbia – Suicide Severity Rating Scale (C-SSRS) ;Primary end point(s): •The incidence of overall AEs, SAEs, and AEs leading to discontinuation;Timepoint(s) of evaluation of this end point: 26 weeks from Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Absolute values and changes from double-blind (DB) Baseline of Study SEP361 201 and open-label (OL) Baseline of Study SEP361 202 in clinical laboratory tests (hematology, serum chemistry, urinalysis, glucose and lipid panel, prolactin, glycosylated hemoglobin (HbA1c)) •Absolute values and changes from DB Baseline of Study SEP361 201 and OL Baseline of Study SEP361 202 in clinical evaluations (vital signs body weight, BMI, blood pressure [supine and standing], heart rate [supine and standing], 12 lead ECGs) •Frequency and severity of suicidal ideation and suicidal behavior using the C-SSRS •Rate of relapse and time to relapse during the 26 week OL period for subjects who demonstrated a clinical response to 4 weeks of treatment with SEP 363856. Relapse will be defined as the onset of any of the following: ?An increase in PANSS total score = 30% from the PANSS total score at clinical response and a CGI S score = 3 ?Re-hospitalization for worsening of psychosis ?Emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others. •Changes from DB Baseline of Study SEP361 201 and OL Baseline of Study SEP361 202 in PANSS total score and subscale scores (positive, negative, and general psychopathology) •Change from DB Baseline of Study SEP361 201 and OL Baseline of Study SEP361 202 in CGI-S score. •Change from DB Baseline of Study SEP361 201 and OL Baseline of Study SEP361 202 in BNSS total score. •Change from DB Baseline of Study SEP361 201 and OL Baseline of Study SEP361 202 in MADRS total score. •Proportion of subjects who achieve a response, defined as a 20% or greater improvement in PANSS total score from the baseline, and calculated using (1) the DB Baseline of Study SEP361 201 for subjects assigned to double-blind SEP 363856, and (2) the | — |
Countries
Hungary, Romania, Russian Federation, Serbia, Ukraine, United States
Contacts
Public ContactRegulatory and Startup
Quintiles
Outcome results
None listed