Schizophrenia MedDRA version: 18.1 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
ALKS 33
Other descriptive name: SAMIDORPHAN L-MALATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Tablet
Route of adminis
Sponsors
Alkermes Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each subject must meet all of the following inclusion criteria to be qualified to participate in this study. Is age 18–70 years, inclusive, at screening Has a body mass index (BMI) of 18.0–40.0 kg/m2, inclusive at screening Meets criteria for the diagnosis of schizophrenia. Resides in a stable living situation when not hospitalized Is willing and able to provide government-issued identification Additional criteria may apply 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 370 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Has had a psychiatric hospitalization for more than 30 days during the 90 days before screening Subject initiated first antipsychotic treatment within the past 12 months, or <1 year has elapsed since the initial onset of active-phase of schizophrenia symptoms Subject poses a current suicide risk Subject has a history of treatment resistance Subject has a history of poor or inadequate response to treatment with olanzapine Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2-month period prior to screening Subject has a diagnosis of moderate or severe alcohol or drug use disorder Subject has a positive urine drug screen for opioids, amphetamine/methamphetamine, phencyclidine, or cocaine at screening Additional criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the antipsychotic efficacy of ALKS 3831(a fixed-dose combination of olanzapine and samidorphan) in adult subjects with an acute exacerbation of schizophrenia;Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability of ALKS 3831 in adult subjects with an acute exacerbation of schizophrenia;Primary end point(s): The primary efficacy endpoint is change from baseline in Positive and Negative Syndrome Scale (PANSS) total score at Week 4.;Timepoint(s) of evaluation of this end point: Baseline and week 4, also assessed throughout at weeks 1, 2 and 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary efficacy endpoint is change from baseline in Modified Overt Aggression Scale (MOAS) total score at Week 2;Timepoint(s) of evaluation of this end point: Baseline and week 2, also assessed at week 1 | — |
Countries
Bulgaria, Hungary, Serbia, Slovakia, Ukraine, United States
Contacts
Public ContactClinical Development
Alkermes Inc
Outcome results
None listed