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This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Experimental | Regular injections |
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| Treatment Group 2 | Active Comparator | Regular injections |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole Lauroxil | Combination Product | Intramuscular injection; study drug provided using a pre-filled syringe |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition. | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Least squares mean change in Positive and Negative Syndrome Scale (PANSS) between at 4 weeks from Mixed Models Repeated Measures (MMRM). The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition |
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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 | 72211 | United States | ||
| Alkermes Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39145678 | Derived | Sommi RW, Saklad SR, Weiden PJ, Still D, Wang M, Yagoda S. Initiating Aripiprazole Lauroxil: Post Hoc Analysis of Safety and Tolerability of 1-Day and 21-Day Regimens. J Clin Psychiatry. 2024 Aug 12;85(3):23m15132. doi: 10.4088/JCP.23m15132. | |
| 38416865 | Derived | Citrome L, Yagoda S, Bidollari I, Wang M. Safety and Tolerability of Starting Aripiprazole Lauroxil With Aripiprazole Lauroxil NanoCrystal Dispersion in 1 Day Followed by Aripiprazole Lauroxil Every 2 Months Using Paliperidone Palmitate Monthly as an Active Control in Patients With Schizophrenia: A Post Hoc Analysis of a Randomized Controlled Trial. J Clin Psychiatry. 2024 Feb 28;85(1):23m15095. doi: 10.4088/JCP.23m15095. |
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Of the 200 patients enrolled and randomized to treatment, there were 195 patients included in the full analysis set. These were patients who randomized, received 1 dose study drug and had at least one post-baseline Positive and Negative Syndrome Scale (PANSS) assessment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole Lauroxil | Aripiprazole lauroxil (AL)1-day initiation regimen (30mg oral aripiprazole + intramuscular injection aripiprazole lauroxil nano-cyrstalline milled dispersion [AL-NCD]) on day 1, followed by 1064mg intramuscular injection aripiprazole lauroxil on day 8 and every 2 months thereafter |
| FG001 |
| 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 | Jan 4, 2018 | Jun 30, 2020 |
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| Paliperidone Palmitate | Drug | Intramuscular injection |
|
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| Baseline and 4 weeks |
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9 | Change within treatment groups from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition. | Baseline and 9 weeks |
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25 | Change within treatment groups at baseline Positive and Negative Syndrome Scale (PANSS) and at 25 weeks based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition | Baseline and 25 weeks |
| Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9 | Least squares mean change from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks from Mixed Models Repeated Measures (MMRM).The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition | Baseline and 9 weeks |
| Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25 | Least squares mean change in Positive and Negative Syndrome Scale (PANSS) total score at week 25 from Mixed Models Repeated Measures. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition | Baseline and 25 weeks |
| Number of Participants With Serious and Non-serious Adverse Events (AEs) | Up to 25 weeks |
| Rogers |
| Arkansas |
| 72758 |
| United States |
| Alkermes Investigational Site | Cerritos | California | 90703 | United States |
| Alkermes Investigational Site | Culver City | California | 90230 | United States |
| Alkermes Investigational Site | Garden Grove | California | 92845 | United States |
| Alkermes Investigational Site | Lemon Grove | California | 91945 | United States |
| Alkermes Investigational Site | Hialeah | Florida | 33012 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60640 | United States |
| Alkermes Investigational Site | Hoffman Estates | Illinois | 60169 | United States |
| Alkermes Investigational Site | Flowood | Mississippi | 39232 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63141 | United States |
| Alkermes Investigational Site | Las Vegas | Nevada | 89102 | United States |
| Alkermes Investigational Site | Berlin | New Jersey | 08009 | United States |
| Alkermes Investigational Site | Austin | Texas | 78754 | United States |
| Alkermes Investigational Site | Garland | Texas | 75042 | United States |
| Alkermes Investigational Site | Richardson | Texas | 75080 | United States |
| 34625041 | Derived | Nasrallah HA, Weiden PJ, Walling DP, Du Y, Yao B, Yagoda S, Claxton A. Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study. BMC Psychiatry. 2021 Oct 8;21(1):492. doi: 10.1186/s12888-021-03420-x. |
| 32433835 | Derived | Weiden PJ, Claxton A, Kunovac J, Walling DP, Du Y, Yao B, Yagoda S, Bidollari I, Keane E, Cash E. Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study. J Clin Psychiatry. 2020 May 19;81(3):19m13207. doi: 10.4088/JCP.19m13207. |
| Paliperidone Palmitate |
Paliperidone palmitate (PP) initiation dosing (234mg intramuscular injection on day 1 + 156mg intramuscular injection on day 8), followed by 156mg intramuscular injection paliperidone palmitate every month thereafter |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole Lauroxil | Aripiprazole lauroxil (AL)1-day initiation regimen (30mg oral aripiprazole + intramuscular injection aripiprazole lauroxil nano-cyrstalline milled dispersion [AL-NCD]) on day 1, followed by 1064mg intramuscular injection aripiprazole lauroxil on day 8 and every 2 months thereafter |
| BG001 | Paliperidone Palmitate | Paliperidone palmitate (PP) initiation dosing (234mg intramuscular injection on day 1 + 156mg intramuscular injection on day 8), followed by 156mg intramuscular injection paliperidone palmitate every month thereafter |
| BG002 | Total | Total of all reporting groups |
| 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Positive and Negative Syndrome Scale (PANSS) Total Score | The Positive and Negative Syndrome Scale (PANSS) contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition. | FAS population includes those who were randomized and received at least one dose of study drug and have at least one post-baseline Positive and Negative Syndrome Scale (PANSS) assessment | Mean | Standard Deviation | units on a scale |
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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 in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition. | The analysis is based on the subjects who had both baseline and observed week 4 Positive and Negative Syndrome Scale (PANSS) data (160 participants). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 4 weeks |
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| Secondary | Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 | Least squares mean change in Positive and Negative Syndrome Scale (PANSS) between at 4 weeks from Mixed Models Repeated Measures (MMRM). The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition | The analysis is based on the subjects who had both baseline and observed week 4 Positive and Negative Syndrome Scale (PANSS) data (160 participants). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 4 weeks |
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| Secondary | Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9 | Change within treatment groups from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition. | The analysis is based on the subjects who had both baseline and observed week 9 Positive and Negative Syndrome Scale (PANSS) data (131 participants). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 9 weeks |
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| Secondary | Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25 | Change within treatment groups at baseline Positive and Negative Syndrome Scale (PANSS) and at 25 weeks based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition | The analysis is based on the subjects who had both baseline and observed week 25 Positive and Negative Syndrome Scale (PANSS) data (99 participants). | Posted | Mean | Standard Deviation | units on a scale | Baseline and 25 weeks |
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| Secondary | Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9 | Least squares mean change from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks from Mixed Models Repeated Measures (MMRM).The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition | The analysis is based on the subjects who had both baseline and observed week 9 PANSS data (131 participants). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 9 weeks |
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| Secondary | Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25 | Least squares mean change in Positive and Negative Syndrome Scale (PANSS) total score at week 25 from Mixed Models Repeated Measures. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition | The analysis is based on the subjects who had both baseline and observed week 25 Positive and Negative Syndrome Scale (PANSS) data (99 participants). | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 25 weeks |
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| Secondary | Number of Participants With Serious and Non-serious Adverse Events (AEs) | Participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Up to 25 weeks |
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Adverse event data was collected over 25 weeks.
Adverse event collection was based on investigator's observation and reporting from subjects.
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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 | Aripiprazole lauroxil (AL)1-day initiation regimen (30mg oral aripiprazole + intramuscular injection aripiprazole lauroxil nano-cyrstalline milled dispersion [AL-NCD]) on day 1, followed by 1064mg intramuscular injection aripiprazole lauroxil on day 8 and every 2 months thereafter | 0 | 99 | 8 | 99 | 39 | 99 |
| EG001 | Paliperidone Palmitate | Paliperidone palmitate (PP) initiation dosing (234mg intramuscular injection on day 1 + 156mg intramuscular injection on day 8), followed by 156mg intramuscular injection paliperidone palmitate every month thereafter | 0 | 101 | 7 | 101 | 50 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Alcohol poisoning | Injury, poisoning and procedural complications | Systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
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| Bone deformity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Dystonia | Nervous system disorders | Systematic Assessment |
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| Generalised tonic-clonic seizure | Nervous system disorders | Systematic Assessment |
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| Schizophrenia | Psychiatric disorders | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | Systematic Assessment |
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| Depression | Psychiatric disorders | Systematic Assessment |
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| Psychotic symptom | Psychiatric disorders | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Pain | General disorders | Systematic Assessment |
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| Weight increased | Investigations | Systematic Assessment |
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| Akathisia | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Dystonia | Nervous system disorders | 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 | |
|---|---|---|---|---|
| Eva Stroynowski | Alkermes, Inc | 7816097000 | eva.stroynowski@alkermes.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2019 | Jun 30, 2020 | SAP_001.pdf |
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| 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 |
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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