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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 9072, Low Dose | Experimental |
| |
| ALKS 9072, High Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 9072, Low Dose | Drug | Intramuscular injection, given monthly |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Risinger, MD | 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 |
|---|---|---|---|
| 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. | |
| 32841554 | Derived | Lauriello J, Claxton A, Du Y, Weiden PJ. Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study. J Clin Psychiatry. 2020 Aug 18;81(5):19m12835. doi: 10.4088/JCP.19m12835. |
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Subjects who successfully completed the treatment period in Study ALK9072-003EXT and continued to meet eligibility criteria were eligible to enroll in this extension study.
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| 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ALKS 9072, High Dose |
| Drug |
Intramuscular injection, given monthly |
|
| 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 |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Alkermes Investigational Site | Garden Grove | California | 92845 | United States |
| Alkermes Investigational Site | Oakland | California | 94612 | United States |
| Alkermes Investigational Site | Oceanside | California | 92056 | United States |
| Alkermes Investigational Site | Orange | California | 92868 | United States |
| Alkermes Investigational Site | Washington D.C. | District of Columbia | 20016 | United States |
| Alkermes Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| Alkermes Investigational Site | Leesburg | Florida | 34748 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30308 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60611 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60640 | United States |
| Alkermes Investigational Site | Hoffman Estates | Illinois | 60169 | United States |
| Alkermes Investigational Site | Shreveport | Louisiana | 71101 | United States |
| Alkermes Investigational Site | Oklahoma City | Oklahoma | 73116 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75231 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75243 | United States |
| Alkermes Investigational Site | Burgas | Bulgaria |
| Alkermes Investigational Site | Novi Iskar | Bulgaria |
| Alkermes Investigational Site | Pazardzhik | Bulgaria |
| Alkermes Investigational Site | Plovdiv | Bulgaria |
| Alkermes Investigational Site | Sofia | Bulgaria |
| Alkermes Investigational Site | Targovishte | Bulgaria |
| Alkermes Investigational Site | Veliko Tarnovo | Bulgaria |
| Alkermes Investigational Site | Vratsa | Bulgaria |
| Alkermes Investigational Site | Cheras | Malaysia |
| Alkermes Investigational Site | Johor Bahru | Malaysia |
| Alkermes Investigational Site | Kuala Lampur | Malaysia |
| Alkermes Investigational Site | Kuching | Malaysia |
| Alkermes Investigational Site | Mariveles | Bataan | Philippines |
| Alkermes Investigational Site | Cebu City | Philippines |
| Alkermes Investigational Site | Iloilo City | Philippines |
| Alkermes Investigational Site | Mandaluyong | Philippines |
| Alkermes Investigational Site | Manila | Philippines |
| Alkermes Investigational Site | Bucharest | Romania |
| Alkermes Investigational Site | Oradea | Romania |
| Alkermes Investigational Site | Târgu Mureş | Romania |
| Alkermes Investigational Site | Roshchino | Vyborgskiy | Russia |
| Alkermes Investigational Site | Lipetsk | Russia |
| Alkermes Investigational Site | Moscow | Russia |
| Alkermes Investigational Site | Rostov-on-Don | Russia |
| Alkermes Investigational Site | Saint Petersburg | Russia |
| Roshchino township | Samara | Russia |
| Roshchino township | Saratov | Russia |
| Alkermes Investigational Site | Stavropol | Russia |
| Alkermes Investigational Site | Talagi | Russia |
| Alkermes Investigational Site | Yaroslavl | Russia |
| Alkermes Investigational Site | Jeollanam-do | South Korea |
| Alkermes Investigational Site | Chernihiv | Ukraine |
| Alkermes Investigational Site | Donetsk | Ukraine |
| Alkermes Investigational Site | Kharkiv | Ukraine |
| Alkermes Investigational Site | Kherson | Ukraine |
| Alkermes Investigational Site | Kyiv | Ukraine |
| Alkermes Investigational Site | Lviv | Ukraine |
| Alkermes Investigational Site | Poltava | Ukraine |
| Alkermes Investigational Site | Ternopil | Ukraine |
| Roshchino township | Vinnytsia | 61068 | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
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Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study.
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| 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs) | This measure includes all incidences, including those that occurred >5%. | Safety population includes all subjects who received at least 1 dose of ALKS 9072 in the current study. | Posted | Count of Participants | Participants | Up to 12 months |
|
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | 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 | Up to 12 months |
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | The full analysis set consists of all subjects who received at least 1 dost 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 | Up to 12 months |
|
|
Adverse events were collected at every study visit for up to 35 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 | ALKS 9072, Low | ALKS 9072, Low : IM injection, given monthly | 0 | 65 | 0 | 65 | 11 | 65 |
| EG001 | ALKS 9072, High | ALKS 9072, High: IM injection, given monthly | 0 | 226 | 4 | 226 | 26 | 226 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Squamous cell carcinoma of lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment | worsening/exacerbation of schizophrenia |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (17.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Non-systematic Assessment |
|
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 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Asian |
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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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| Romania |
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| United States |
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| Philippines |
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| Ukraine |
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| Malaysia |
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| Bulgaria |
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| Russia |
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