A Long-term Safety Study of ALKS 9072 (Also Known as ALKS... | NCT01626456

Label	Type	Description	Intervention Names
ALKS 9072, Low	Experimental		Drug: ALKS 9072, Low
ALKS 9072, High	Experimental		Drug: ALKS 9072, High

Name	Type	Description	Arm Group Labels	Other Names
ALKS 9072, Low	Drug	IM injection, given monthly	ALKS 9072, Low
ALKS 9072, High

Measure	Description	Time Frame
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)	This measure includes incidences >5%.	52 weeks

Measure	Description	Time Frame
Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)	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.

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Alkermes Medical Director	Alkermes, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alkermes Investigational Site		Little Rock	Arkansas	72201	United States
Alkermes Investigational Site

PubMed Identifier	Type	Citation	Retractions
28350572	Result	Hard ML, Mills RJ, Sadler BM, Turncliff RZ, Citrome L. Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia. J Clin Psychopharmacol. 2017 Jun;37(3):289-295. doi: 10.1097/JCP.0000000000000691.
33761928	Derived	McEvoy JP, Weiden PJ, Lysaker PH, Sun X, O'Sullivan AK. Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia. BMC Psychiatry. 2021 Mar 24;21(1):164. doi: 10.1186/s12888-021-03124-2.

Results Section

Participant Flow Module

ID	Title	Description
FG000	ALKS 9072, Low	ALKS 9072, Low: IM injection, given monthly
FG001	ALKS 9072, High	ALKS 9072, High: IM injection, given monthly

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With Treatment-emergent Adverse Events (TEAEs)

This measure includes incidences >5%.

Safety population includes all subjects who receive at least 1 dose of ALKS 9072 in the current study.

Posted

Number

participants

52 weeks

ID	Title	Description
OG000	ALKS 9072, Low	ALKS 9072, Low: IM injection, given monthly
OG001	ALKS 9072, High	ALKS 9072, High: IM injection, given monthly

Units	Counts
Participants	OG000110 OG001368

Title

Denominators

Categories

Title	Measurements
	OG00051 OG001190

Secondary

Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)

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.

The full analysis set consists of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS score after administration of ALKS 9072.

Posted

Mean

Standard Deviation

units on a scale

52 weeks

ID	Title	Description
OG000	PBO-441 mg	Subjects who received placebo in the base study and low dose in the current study.
OG001	441-441 mg	Subjects who received low dose in both the base study and the current study.
OG002	PBO-882 mg	Subjects who received placebo in the base study and high dose in the current study.

Secondary

Discontinuation From Study Due to Adverse Events (AEs)

Number of subjects who discontinued the study due to AE.

Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.

Posted

Number

participants

52 weeks

ID	Title	Description
OG000	ALKS 9072, Low	ALKS 9072, Low: IM injection, given monthly
OG001	ALKS 9072, High	ALKS 9072, High: IM injection, given monthly

Units	Counts
Participants	OG000

Secondary

Suicidal Ideation and Behavior Using the Columbia Suicide Severity Rating Scale (C-SSRS)

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.

Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.

Posted

Number

participants

52 weeks

ID	Title	Description
OG000	PBO-440 mg	Subjects who received placebo in the base study and low dose in the current study
OG001	441-441 mg	Subjects who received low dose in the base study and in the current study.
OG002	PBO-882 mg	Subjects who received placebo in the base study and high dose in the current study.
OG003	882-882 mg	Subjects who received high dose in the base study and the current study.

Secondary

Incidence of Clinically Significant Changes Will be Calculated for Movement Disorders, Vital Signs and Routine Laboratory Tests

Includes incidence >2% but <5%.

Posted

Number

participants

52 weeks

ID	Title	Description
OG000	PBO-441 mg	Subjects who received placebo in the base study and low dose in the current study.
OG001	441-441 mg	Subjects who received low dose in both the base study and the current study.
OG002	PBO-882 mg	Subjects who received placebo in the base study and high dose in the current study.
OG003	882-882 mg	Subjects who received high dose in both the base study and the current study.
OG004	De Novo	Subjects who did not participate in the base study. These subjects received high dose.

Secondary

Mean Change From Baseline to Endpoint Using the Positive and Negative Symptom Scale (PANSS) Total Score and Subscale Scores

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).

The full analysis set consisted of all subjects who received at least 1 dose of ALKS 9072 and had at least 1 postbaseline assessment of PANSS total score after administration of ALKS 9072.

Posted

Mean

Standard Deviation

units on a scale

52 weeks

ID	Title	Description
OG000	PBO-441 mg	Subjects who received placebo in the base study and low dose in the current study.
OG001	441-441 mg	Subjects who received low dose in both the base study and the current study.
OG002	PBO-882 mg	Subjects who received placebo in the base study and high dose in the current study.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Schizophrenia	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0012 events2 affected368 at risk
Aggression	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Completed suicide	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Depressed mood	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Drug abuse	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Somatoform disorder cardiovascular	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Adenomyosis	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0012 events2 affected368 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 events0 affected110 at risk EG0011 events1 affected368 at risk

ID	Title	Description
BG000	ALKS 9072, Low	ALKS 9072, Low: IM injection, given monthly
BG001	ALKS 9072, High	ALKS 9072, High: IM injection, given monthly
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ALKS 9072, Low	ALKS 9072, Low: IM injection, given monthly			0	110	16	110
EG001	ALKS 9072, High	ALKS 9072, High: IM injection, given monthly			15	368	59	368

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Weight increased	Investigations	MedDRA	Non-systematic Assessment	EG0008 events7 affected110 at risk EG00117 events17 affected368 at risk
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment	EG00010 events7 affected110 at risk EG00115 events11 affected368 at risk
Insomnia	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0004 events3 affected110 at risk EG00145 events37 affected368 at risk

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders