An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

Study Overview
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Brief Summary
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This is an extension of a previous study (ALK9072-003EXT). The purpose of this study is to continue to evaluate the long-term safety and durability of effect of ALKS 9072 in subjects with stable schizophrenia, and to allow subjects who are doing well on ALKS 9072 to continue treatment.

Official Title
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A Phase 3, Multicenter Extension of Study ALK9072-003EXT to Assess the Long-term Safety and Durability of Effect of ALKS 9072 in Subjects With Stable Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: ALKS 9072, Low Dose
* Drug: ALKS 9072, High Dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completed the treatment period of Study ALK9072-003EXT Continues to require chronic treatment with an antipsychotic medication Continues to reside in a stable living situation Continues to have an identified reliable informant Exclusion Criteria: Abnormal clinical laboratory value, vital sign, or electrocardiogram (ECG) finding during participation in Study ALK9072-003EXT that was clinically relevant and related to study drug Missed more than 1 scheduled study visit during participation in the preceding Study ALK9072-003EXT Has a significant or unstable medical condition that would preclude safe completion of the current study Subject is pregnant or breastfeeding Subject expects to be incarcerated, or has pending legal action which may impact compliance with study participation or procedures

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 9072, Low Dose<br> | Drug: ALKS 9072, Low Dose<br>* Intramuscular injection, given monthly<br>|
| Experimental: ALKS 9072, High Dose<br> | Drug: ALKS 9072, High Dose<br>* Intramuscular injection, given monthly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) | This measure includes all incidences, including those that occurred >5%. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time | 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 the subject's last visit in the treatment period. | Up to 12 months | 
| Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time | 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 Day 365 based on the observed data. Change is calculated between the baseline visit and the subject's last visit in the treatment period. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia