A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)

Phase 3

Completed

Conditions: Schizophrenia

Interventions: Drug: ALKS 9072, High
Drug: ALKS 9072, Low

Registration Number: NCT01626456

Lead Sponsor: Alkermes, Inc.

Brief Summary: This study will evaluate the safety and durability of effect of ALKS 9072 (also known as ALKS 9070) during long-term treatment of subjects with stable schizophrenia.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 478

Inclusion Criteria

(Subjects who participated in ALK9072-003)

Completed the ALK9072-003 Day 85 visit
Continues to require treatment with an antipsychotic medication

(New Subjects)

On a stable dose of oral antipsychotic medication
Diagnosis of chronic schizophrenia based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria that is clinically stable
Has been able to achieve outpatient status for more than 3 months prior to screening
Body Mass Index (BMI) of 18.5 to 40.0 kg/m2 (inclusive)
Resides in a stable living situation

Exclusion Criteria

(Subjects who participated in ALK9072-003)

Abnormal clinical laboratory, vital sign, or electrocardiogram (ECG) finding during participation in study ALK9072-003 that was clinically relevant and related to study drug
Missed more than 1 scheduled study visit during participation in study ALK9072-003
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 in the next 12 months, or has pending legal action which may impact compliance with study participation or procedures

(New Subjects)

History of poor or inadequate clinical response to treatment with aripiprazole
History of treatment resistance
Diagnosis of current substance dependence (including alcohol)
Pregnant, lactating, or breastfeeding
Has received any long-acting intramuscular antipsychotic medication within 60 days prior to screening
Currently under involuntary hospitalization
Current or expected incarceration

Additional inclusion/exclusion criteria may apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALKS 9072, High	ALKS 9072, High	-
ALKS 9072, Low	ALKS 9072, Low	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)	52 weeks	This measure includes incidences \>5%.

Secondary Outcome Measures

Name	Time	Method
Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests	52 weeks	Includes incidence \>2% but \<5%.
Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores	52 weeks	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), 7 (positive/negative subscales), and 16 (general subscale); maximum scores (worst outcome) equals 210 (total scale), 49 (positive/negative subscales), and 112 (general subscale).
Discontinuation From Study Due to Adverse Events (AEs)	52 weeks	Number of subjects who discontinued the study due to AE.
Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)	52 weeks	The C-SSRS is a questionnaire used for suicide assessment. Subjects are asked a series of questions that determine whether or not the patient demonstrates any suicidal ideation or behavior. The C-SSRS was administered to subjects at each study visit.
Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)	52 weeks	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.