A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

Study Overview
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Brief Summary
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This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.

Official Title
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A Phase 3 Study to Determine the Antipsychotic Efficacy and Safety of ALKS 3831 in Adult Subjects With Acute Exacerbation of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: ALK3831
* Drug: Olanzapine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a body mass index (BMI) of 18.0 - 40.0 kg/m^2 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALKS 3831<br>Administered as a coated bilayer tablet | Drug: ALK3831<br>* Daily dosing<br>|
| Active Comparator: Olanzapine<br>Administered as a coated bilayer tablet | Drug: Olanzapine<br>* Daily dosing<br>|
| Placebo Comparator: Placebo<br>Administered as a coated bilayer tablet | Drug: Placebo<br>* Daily dosing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | This scale consists of symptom constructs (7 positive, 7 negative, 16 general psychopathology), each to be rated on a 7-point Likert-type scale of severity with 1 being absent to 7 being extreme. Minimum scores (best outcome) equals 30 (total scale); maximum scores (worst outcome) equals 210 (total scale). Change is calculated between the baseline visit and Week 4. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Clinical Global Impressions-Severity (CGIS) Score at Week 4 | The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to Week 4 based on the observed data. Change is calculated between the baseline visit and Week 4. | 4 weeks | 
| Incidence of Adverse Events |  | Approximately 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkermes, ALKS 3831, Samidorphan, Schizophrenia, Acute Exacerbation of Schizophrenia