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This study will evaluate the safety and tolerability of aripiprazole lauroxil (also known as ARISTADA, ALKS 9070).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aripiprazole Lauroxil | Other | Intramuscular (IM) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole Lauroxil | Drug | Monthly IM injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores | 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 last visit in the treatment period based on the observed data. | Up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores | The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjeev Pathak, MD | Alkermes, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Little Rock | Arkansas | 27711 | United States | ||
| Alkermes Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38495608 | Derived | Opler MGA, Claxton A, McGrory J, Gasper S, Wang M, Yagoda S. Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis. Innov Clin Neurosci. 2024 Mar 1;21(1-3):43-51. eCollection 2024 Jan-Mar. |
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All subjects received 4 to 6 doses of aripiprazole lauroxil in monthly or 6-week intervals.
Subjects had schizophrenia, and had been taking paliperidone palmitate (PP) or Risperidone long-acting injection (RLAI) with inadequate results for at least 3 doses prior to screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole Lauroxil | Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 7, 2016 | Jul 11, 2018 |
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| Up to 7 months |
| Number of Participants With Adverse Events | Up to 7 months |
| Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS) | The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). | Up to 7 months |
| Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6) | Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period. | Up to 7 months |
| Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS) | The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - 'Not at all', 'A little', 'Some' or "A lot' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit. | Up to 7 months |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Alkermes Investigational Site | Anaheim | California | 92805 | United States |
| Alkermes Investigational Site | Culver City | California | 90230 | United States |
| Alkermes Investigational Site | Garden Grove | California | 92845 | United States |
| Alkermes Investigational Site | National City | California | 91950 | United States |
| Alkermes Investigational Site | Oceanside | California | 92056 | United States |
| Alkermes Investigational Site | Orange | California | 92868 | United States |
| Alkermes Investigational Site | Panorama City | California | 91402 | United States |
| Alkermes Investigational Site | Augusta | Georgia | 30901 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60640 | United States |
| Alkermes Investigational Site | Shreveport | Louisiana | 71101 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63141 | United States |
| Alkermes Investigational Site | Garfield Heights | Ohio | 44125 | United States |
| Alkermes Investigational Site | Lincoln | Rhode Island | 02865 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75231 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75243 | United States |
| Alkermes Investigational Site | DeSoto | Texas | 75115 | United States |
| COMPLETED |
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| NOT COMPLETED |
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The Safety population included all subjects who received at least one dose of study drug. All analyses were performed on the Safety population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole Lauroxil | Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores | 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 last visit in the treatment period based on the observed data. | Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit. | Posted | Mean | Standard Deviation | units on a scale | Up to 7 months |
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| Secondary | Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores | The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology). | Safety population includes all subjects who received at least 1 dose of study drug and had a last on-treatment visit. | Posted | Mean | Standard Deviation | units on a scale | Up to 7 months |
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| Secondary | Number of Participants With Adverse Events | Safety population includes all subjects who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Up to 7 months |
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| Secondary | Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS) | The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). | Subjects who had at least one dose of study drug and had a last on-treatment visit. | Posted | Mean | Standard Deviation | units on a scale | Up to 7 months |
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| Secondary | Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6) | Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period. | Posted | Number | participants | Up to 7 months |
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| Secondary | Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS) | The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - 'Not at all', 'A little', 'Some' or "A lot' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit. | Subjects who received at least one dose of study drug, had a last on-treatment visit, and had an unpaid caregiver providing information. | Posted | Mean | Standard Deviation | units on a scale | Up to 7 months |
|
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Up to 7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aripiprazole Lauroxil | Intramuscular (IM) injection Aripiprazole Lauroxil: Monthly IM injection | 0 | 51 | 5 | 51 | 3 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychotic disorder | Psychiatric disorders | MedDRA V19 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
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Should an Investigator desire to disclose study results, Sponsor will review the results disclosure prior to public release and can embargo the disclosure for a period of at least 60 days. Revisions to the disclosure will be negotiated in good faith. For a multicenter study the Investigators agree to publish/publicly present the results together with the other sites for the 12 month period after study results are available unless Sponsor grants written permission in advance.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ARISTADA Medical Information | Alkermes, Inc. | 866-204-7823 | usmedinfo@alkermes.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2017 | Jul 11, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000603935 | aripiprazole lauroxil |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Categories |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Spent at least 1 overnight as an inpatient |
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| Attended an outpatient visit for mental health |
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| Had at least 1 visit to an ER |
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| Were arrested, picked up, or transported by police |
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