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The study will determine the efficacy of ALKS 9072 (also known as aripiprazole lauroxil or ALKS 9070) for the treatment of schizophrenia in subjects experiencing an acute exacerbation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 9072 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 9072 | Drug | Intramuscular (IM) injection, 441 mg or 882 mg given monthly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score | 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. | Data collected from baseline to day 85 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression - Improvement (CGI-I) Scores at Day 85 | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: "1: very much improved"; "2: much improved"; "3: minimally improved"; "4: no change"; "5: minimally worse"; "6: much worse"; or "7: very much worse". |
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Inclusion Criteria:
Exclusion Criteria:
Additional inclusion/exclusion criteria may apply.
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| 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 |
|---|---|---|---|
| 27707530 | Result | Targum SD, Risinger R, Du Y, Pendergrass JC, Jamal HH, Silverman BL. Effect of patient age on treatment response in a study of the acute exacerbation of psychosis in schizophrenia. Schizophr Res. 2017 Jan;179:64-69. doi: 10.1016/j.schres.2016.09.034. Epub 2016 Oct 1. | |
| 27574838 | Result | Nasrallah HA, Newcomer JW, Risinger R, Du Y, Zummo J, Bose A, Stankovic S, Silverman BL, Ehrich EW. Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia. J Clin Psychiatry. 2016 Nov;77(11):1519-1525. doi: 10.4088/JCP.15m10467. |
| Label | URL |
|---|---|
| Russian clinical trials website | View source |
Not provided
Subjects were admitted to an inpatient study unit. Currently prescribed antipsychotics were discontinued prior to administration of study drug. One randomized subject was discontinued for a protocol violation prior to receiving investigational treatment.
Included subjects with schizophrenia experiencing an acute exacerbation episode.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aripiprazole Lauroxil 441 mg | Intramuscular injection, given monthly |
| FG001 | Aripiprazole Lauroxil 882 mg | Intramuscular injection, given monthly |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Placebo for IM injection, given monthly |
|
| 85 Days |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Alkermes Investigational Site | Springdale | Arkansas | 72764 | United States |
| Alkermes Investigational Site | Cerritos | California | 90703 | United States |
| Alkermes Investigational Site | Garden Grove | California | 92845 | United States |
| Alkermes Investigational Site | La Habra | California | 90631 | 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 | San Diego | California | 92123 | 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 | 60640 | United States |
| Alkermes Investigational Site | Hoffman Estates | Illinois | 60169 | United States |
| Alkermes Investigational Site | Overland Park | Kansas | 66212 | United States |
| Alkermes Investigational Site | Rockville | Maryland | 20850 | United States |
| Alkermes Investigational Site | Creve Coeur | Missouri | 63141 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63118 | United States |
| Alkermes Investigational Site | Philadelphia | Pennsylvania | 19139 | United States |
| Alkermes Investigational Site | Charleston | South Carolina | 29407 | United States |
| Alkermes Investigational Site | Austin | Texas | 78731 | United States |
| Alkermes Investigational Site | Austin | Texas | 78754 | 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 | Kazanlak | Bulgaria |
| Alkermes Investigational Site | Novi Iskar | Bulgaria |
| Alkermes Investigational Site | Pazardzhik | Bulgaria |
| Alkermes Investigational Site | Pleven | Bulgaria |
| Alkermes Investigational Site | Plovdiv | Bulgaria |
| Alkermes Investigational Site | Radnevo | Bulgaria |
| Alkermes Investigational Site | Rousse | Bulgaria |
| Alkermes Investigational Site | Sofia | Bulgaria |
| Alkermes Investigational Site | Stara Zagora | 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 Lumpur | 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 | Pasig | Philippines |
| Alkermes Investigational Site | Oradea | Bihor County | Romania |
| Alkermes Investigational Site | Bucharest | 030455 | Romania |
| Alkermes Investigational Site | Bucharest | Romania |
| Alkermes Investigational Site | Craiova | Romania |
| Alkermes Investigational Site | Iași | Romania |
| Alkermes Investigational Site | Târgu Mureş | Romania |
| Alkermes Investigational Site | Nikol’skoye | Gatchinckiy | Russia |
| Alkermes Investigational Site | Staritsa | Orenburg Oblast | Russia |
| Alkermes Investigational Site | Talagi | Primorskiy (Maritime) Kray | Russia |
| Alkermes Investigational Site | Khot'kovo | Sergievo-Posadskiy | Russia |
| Alkermes Investigational Site | Lipetsk | Russia |
| Alkermes Investigational Site | Moscow | Russia |
| Alkermes Investigational Site | Nizhny Novgorod | Russia |
| Alkermes Investigational Site | Rostov-on-Don | Russia |
| Alkermes Investigational Site | Saint Petersburg | Russia |
| Alkermes Investigational Site | Samara | Russia |
| Alkermes Investigational Site | Saratov | Russia |
| Alkermes Investigational Site | Stavropol | Russia |
| Alkermes Investigational Site | Voronezh | Russia |
| Alkermes Investigational Site | Yaroslavl | Russia |
| Alkermes Investigational Site | Jeju City | South Korea |
| Alkermes Investigational Site | Jeollanam-do | South Korea |
| Alkermes Investigational Site | Seoul | South Korea |
| Alkermes Investigational Site | Stepanivka | Kherson Oblast | Ukraine |
| Alkermes Investigational Site | Chernihiv | Ukraine |
| Alkermes Investigational Site | Donetsk | Ukraine |
| Alkermes Investigational Site | Kharkiv | Ukraine |
| Alkermes Investigational Site | Kyiv | Ukraine |
| Alkermes Investigational Site | Luhansk | Ukraine |
| Alkermes Investigational Site | Lviv | Ukraine |
| Alkermes Investigational Site | Poltava | Ukraine |
| Alkermes Investigational Site | Simferopol | Ukraine |
| Alkermes Investigational Site | Ternopil | Ukraine |
| Alkermes Investigational Site | Uzhhorod | Ukraine |
| Alkermes Investigational Site | Vinnytsia | Ukraine |
| 26517202 | Result | Citrome L, Du Y, Risinger R, Stankovic S, Claxton A, Zummo J, Bose A, Silverman BL, Ehrich EW. Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia. Int Clin Psychopharmacol. 2016 Mar;31(2):69-75. doi: 10.1097/YIC.0000000000000106. |
| 26114240 | Result | Meltzer HY, Risinger R, Nasrallah HA, Du Y, Zummo J, Corey L, Bose A, Stankovic S, Silverman BL, Ehrich EW. A randomized, double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015 Aug;76(8):1085-90. doi: 10.4088/JCP.14m09741. |
| 28342578 | Result | Potkin SG, Risinger R, Du Y, Zummo J, Bose A, Silverman B, Stankovic S, Ehrich E. Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation. Schizophr Res. 2017 Dec;190:115-120. doi: 10.1016/j.schres.2017.03.003. Epub 2017 Mar 23. |
| 28712616 | Result | Cameron C, Zummo J, Desai DN, Drake C, Hutton B, Kotb A, Weiden PJ. Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison. Value Health. 2017 Jul-Aug;20(7):876-885. doi: 10.1016/j.jval.2017.03.010. Epub 2017 May 9. |
| 28625204 | Result | Citrome L, Risinger R, Cutler AJ, Du Y, Zummo J, Nasrallah HA, Silverman BL. Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study. CNS Spectr. 2018 Aug;23(4):284-290. doi: 10.1017/S1092852917000396. Epub 2017 Jun 19. |
| 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. |
| 29179595 | Result | Cameron C, Zummo J, Desai D, Drake C, Hutton B, Kotb A, Weiden PJ. Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies. Curr Med Res Opin. 2018 Apr;34(4):725-733. doi: 10.1080/03007995.2017.1410471. Epub 2018 Jan 10. |
| 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. |
| 28937706 | Derived | McEvoy JP, Risinger R, Mykhnyak S, Du Y, Liu CC, Stanford AD, Weiden PJ. Durability of Therapeutic Response With Long-Term Aripiprazole Lauroxil Treatment Following Successful Resolution of an Acute Episode of Schizophrenia. J Clin Psychiatry. 2017 Sep-Oct;78(8):1103-1109. doi: 10.4088/JCP.17m11625. |
| EU Clinical Trials Register; EudraCT number 2012-003445-15 | View source |
| FG002 | Placebo | Intramuscular injection, given monthly |
| COMPLETED |
|
| NOT COMPLETED |
|
Randomized Population
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| ID | Title | Description |
|---|---|---|
| BG000 | Aripiprazole Lauroxil 441 mg | Intramuscular injection, given monthly |
| BG001 | Aripiprazole Lauroxil 882 mg | Intramuscular injection, given monthly |
| BG002 | Placebo | Intramuscular injection, given monthly |
| BG003 | 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, 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 | 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 | The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score | 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. | Full Analysis Set (FAS) defined as all randomized subjects who received at least 1 dose of IM study drug and had at least 1 primary efficacy assessment after administration of IM study drug. | Posted | Least Squares Mean | Standard Error | units on a scale | Data collected from baseline to day 85 |
|
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impression - Improvement (CGI-I) Scores at Day 85 | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the study. Results indicate participants evaluated at one of the following categories: "1: very much improved"; "2: much improved"; "3: minimally improved"; "4: no change"; "5: minimally worse"; "6: much worse"; or "7: very much worse". | FAS, defined as all randomized subjects who received at least 1 IM dose of study drug and had at least 1 primary efficacy assessment after administration of IM study drug. | Posted | Number | participants in category | 85 Days |
|
|
Adverse events were collected during the 85-day treatment period.
One randomized subject was discontinued for a protocol violation prior to receiving IM study drug (placebo), and this subject was not included in the safety population. This changes the overall number of subjects in the placebo group to include 207.
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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 441 mg | Intramuscular injection, given monthly | 3 | 207 | 66 | 207 | ||
| EG001 | Aripiprazole Lauroxil 882 mg | Intramuscular injection, given monthly | 4 | 208 | 68 | 208 | ||
| EG002 | Placebo | Intramuscular injection, given monthly | 4 | 207 | 76 | 207 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina unstable | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Peritoneal adhesions | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Drug Abuse | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Victim of homicide | Social circumstances | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA | 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. | 866-274-7823 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Philippines |
|
| Malaysia |
|
| Ukraine |
|
| Romania |
|
| Bulgaria |
|
| Russian Federation |
|
| 2-Sided |
| Superiority or Other |
| Counts |
|---|
| Participants |
|
|
|