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This study will evaluate the long-term safety, tolerability, and durability of treatment effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I disorder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 3831 | Experimental | Coated bilayer tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 3831 | Drug | Olanzapine + samidorphan, daily oral dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Up to 48 months | |
| Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale | The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients | Up to 48 months |
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Inclusion Criteria:
Exclusion Criteria:
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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 | 72211 | United States | ||
| Alkermes Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39630083 | Derived | Ballon JS, Kahn RS, Arevalo C, Dunbar M, McDonnell D, Correll CU. Long-Term Safety, Tolerability, and Durability of Treatment Effect of Olanzapine and Samidorphan: Results of a 4-Year Open-Label Study. J Clin Psychiatry. 2024 Dec 4;86(1):24m15511. doi: 10.4088/JCP.24m15511. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ALKS 3831 | Coated bilayer tablet ALKS 3831: Olanzapine + samidorphan, daily oral dosing ranging from 5/10, 10/10, 15/10, and 20/10 mg at the Investigator's discretion. |
| 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 | May 9, 2019 | Aug 7, 2024 |
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Open-label
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| Rogers |
| Arkansas |
| 72758 |
| United States |
| Alkermes Investigational Site | Anaheim | California | 92805 | 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 | Glendale | California | 91206 | United States |
| Alkermes Investigational Site | Long Beach | California | 90822 | United States |
| Alkermes Investigational Site | Oakland | California | 94607 | United States |
| Alkermes Investigational Site | Oceanside | California | 92056 | United States |
| Alkermes Investigational Site | Orange | California | 92868 | United States |
| Alkermes Investigational Site | Palo Alto | California | 94305 | United States |
| Alkermes Investigational Site | Pico Rivera | California | 90660 | United States |
| Alkermes Investigational Site | Redlands | California | 92374 | United States |
| Alkermes Investigational Site | San Diego | California | 92013 | United States |
| Alkermes Investigational Site | Temecula | California | 92591 | United States |
| Alkermes Investigational Site | Torrance | California | 90502 | United States |
| Alkermes Investigational Site | Lauderhill | Florida | 33319 | United States |
| Alkermes Investigational Site | North Miami | Florida | 33161 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30303 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30329 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30331 | United States |
| Alkermes Investigational Site | Augusta | Georgia | 30912 | United States |
| Alkermes Investigational Site | Decatur | Georgia | 30030 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60611 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60640 | United States |
| Alkermes Investigational Site | Winfield | Illinois | 60190 | United States |
| Alkermes Investigational Site | Grand Rapids | Michigan | 49503 | United States |
| Alkermes Investigational Site | Flowood | Mississippi | 39232 | United States |
| Alkermes Investigational Site | Kansas City | Missouri | 64108 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63110 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63118 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63128 | 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 | Marlton | New Jersey | 08053 | United States |
| Alkermes Investigational Site | Brooklyn | New York | 11235 | United States |
| Alkermes Investigational Site | Rochester | New York | 14615 | United States |
| Alkermes Investigational Site | Canton | Ohio | 44718 | United States |
| Alkermes Investigational Site | Cincinnati | Ohio | 45219 | United States |
| Alkermes Investigational Site | Dayton | Ohio | 45417 | United States |
| Alkermes Investigational Site | Eugene | Oregon | 97401 | United States |
| Alkermes Investigational Site | Austin | Texas | 78759 | United States |
| Alkermes Investigational Site | DeSoto | Texas | 75115 | United States |
| Alkermes Investigational Site | Fort Worth | Texas | 76104 | United States |
| Alkermes Investigational Site | Houston | Texas | 77030 | United States |
| Alkermes Investigational Site | Richardson | Texas | 75080 | United States |
| Alkermes Investigational Site | Bellevue | Washington | 98007 | United States |
| Alkermes Investigational Site | Vienna | Austria |
| Alkermes Investigational Site | Burgas | Bulgaria |
| Alkermes Investigational Site | Lovech | Bulgaria |
| Alkermes Investigational Site | Novi Iskar | Bulgaria |
| Alkermes Investigational Site | Plovdiv | Bulgaria |
| Alkermes Investigational Site | Sofia | Bulgaria |
| Alkermes Investigational Site | Tserova Koria | Bulgaria |
| Alkermes Investigational Site | Veliko Tarnovo | Bulgaria |
| Alkermes Investigational Site | Vratsa | Bulgaria |
| Alkermes Investigational Site | Galway | Ireland |
| Alkermes Investigational Site | Jerusalem | Israel |
| Alkermes Investigational Site | Ramat Gan | Israel |
| Alkermes Investigational Site | Brescia | Italy |
| Alkermes Investigational Site | Naples | Italy |
| Alkermes Investigational Site | Poznan | Poland |
| Alkermes Investigational Site | San Juan | Puerto Rico |
| Alkermes Investigational Site | Arkhangelsk | Russia |
| Alkermes Investigational Site | Moscow | Russia |
| Alkermes Investigational Site | Roshchino | 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 | Tonnel'nyy | Russia |
| Alkermes Investigational Site | Belgrade | Serbia |
| Alkermes Investigational Site | Kragujevac | Serbia |
| Alkermes Investigational Site | Novi Kneževac | Serbia |
| Alkermes Investigational Site | Busan | South Korea |
| 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 | Smila | Ukraine |
| Alkermes Investigational Site | Vinnytsia | Ukraine |
| Alkermes Investigational Site | Headington | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All analyses were conducted using the safety population except for the analyses of adverse events in the safety follow up period
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| ID | Title | Description |
|---|---|---|
| BG000 | ALKS 3831 | Coated bilayer tablet ALKS 3831: Olanzapine + samidorphan, daily oral dosing |
| 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 |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | Centimeters |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
| ||||||||||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||||||||
| Clinical Global Impression-Severity | The Clinical Global Impression (CGI) is a 3-item, clinician-rated scale used to assess global illness severity, overall improvement from the start of treatment, and therapeutic response. Rate a participant 1-7; from "not at all ill" (ie, score of 1) to "among the most extremely ill" (ie, score of 7) | Mean | Standard Deviation | units on a scale |
|
| 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 | Incidence of Adverse Events | All enrolled participants who received at least 1 dose of study drug | Posted | Count of Participants | Participants | Up to 48 months |
|
|
| |||||||||||||||||||||||||||
| Primary | Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale | The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients | Posted | Mean | Standard Deviation | units on a scale | Up to 48 months |
|
|
Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
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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 3831 | Coated bilayer tablet ALKS 3831: Olanzapine + samidorphan, daily oral dosing | 1 | 523 | 35 | 523 | 314 | 523 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
| ||
| Aortic valve incompetence | Cardiac disorders | Non-systematic Assessment |
| ||
| Pericardial haemorrhage | Cardiac disorders | Non-systematic Assessment |
| ||
| Crohn's disease | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastric Ulcer | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Haematochezia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Mallory-Weiss syndrome | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Obstructive pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Anaphylactic shock | Immune system disorders | Non-systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| Large intestine infection | Infections and infestations | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Accidental overdose | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Concussion | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Craniocerebral injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Femur fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Skull fractured base | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Traumatic haemothorax | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Traumatic liver injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Vena cava injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Blood urine present | Investigations | Non-systematic Assessment |
| ||
| Infected naevus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Drug withdrawal convulsions | Nervous system disorders | Non-systematic Assessment |
| ||
| Intracranial aneursym | Nervous system disorders | Non-systematic Assessment |
| ||
| Schizophrenia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Acute psychosis | Psychiatric disorders | Non-systematic Assessment |
| ||
| Aggression | Psychiatric disorders | Non-systematic Assessment |
| ||
| Completed suicide | Psychiatric disorders | Non-systematic Assessment |
| ||
| Depression Suicidal | Psychiatric disorders | Non-systematic Assessment |
| ||
| Mania | Psychiatric disorders | Non-systematic Assessment |
| ||
| Psychiatric symptom | Psychiatric disorders | Non-systematic Assessment |
| ||
| Psychotic disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Psychotic symptom | Psychiatric disorders | Non-systematic Assessment |
| ||
| Substance-induced psychotic disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Suicide attempt | Psychiatric disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight increased | Investigations | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Weight decreased | Investigations | Non-systematic Assessment |
| ||
| Blood creatine phosphokinase increased | Investigations | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Schizophrenia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Blood triglycerides increased | Investigations | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Low density lipoprotein increased | Investigations | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Non-systematic Assessment |
| ||
| Blood prolactin increased | Investigations | Non-systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | 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 | |
|---|---|---|---|---|
| Global Clinical Services | Alkermes | 888-253-8008 | clinicaltrials@alkermes.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 13, 2023 | Aug 7, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Unknown or Not Reported |
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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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| United Kingdom |
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| Russia |
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| Austria |
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| South Korea |
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| Ireland |
|
| Poland |
|
| Italy |
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| Israel |
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| Bulgaria |
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| Serbia |
|
|