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The primary objective of this study is to evaluate the long-term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 3831 | Experimental | Oral tablet, daily dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 3831 | Drug | Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Adverse Events | Overall summary of treatment emergent adverse events during the treatment period | Up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alkermes Medical Director | Alkermes, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alkermes Investigational Site | Little Rock | Arkansas | 72211 | United States | ||
| Alkermes Investigational Site |
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One patient was enrolled and not dosed. A total of 265 patients were administered at least one dose of ALKS 3831 and included in the safety population.
Subjects that had completed the 24-week treatment period of the antecedent study ALK3831-A303 within seven days prior to enrollment were eligible to be enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALKS 3831 | All subjects assigned to ALKS 3831 ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan Oral tablet, daily dosing |
| 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 | Apr 26, 2018 | Jun 10, 2021 |
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| Springdale |
| Arkansas |
| 72764 |
| 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 | Lemon Grove | California | 91945 | United States |
| Alkermes Investigational Site | Long Beach | California | 90822 | 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 | Pico Rivera | California | 90660 | United States |
| Alkermes Investigational Site | Redlands | California | 92374 | United States |
| Alkermes Investigational Site | San Diego | California | 92103 | United States |
| Alkermes Investigational Site | San Diego | California | 92123 | United States |
| Alkermes Investigational Site | Temecula | California | 92591 | United States |
| Alkermes Investigational Site | Torrance | California | 90502 | United States |
| Alkermes Investigational Site | Hollywood | Florida | 33024 | United States |
| Alkermes Investigational Site | Lauderhill | Florida | 33319 | United States |
| Alkermes Investigational Site | North Miami | Florida | 33161 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30329 | United States |
| Alkermes Investigational Site | Augusta | Georgia | 30912 | United States |
| Alkermes Investigational Site | Decatur | Georgia | 30030 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60640 | United States |
| Alkermes Investigational Site | Grand Rapids | Michigan | 49503 | United States |
| Alkermes Investigational Site | Flowood | Mississippi | 39232 | United States |
| Alkermes Investigational Site | Creve Coeur | Missouri | 63141 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63128 | 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 | Jamaica | New York | 11432 | United States |
| Alkermes Investigational Site | Rochester | New York | 14615 | United States |
| Alkermes Investigational Site | Canton | Ohio | 44718 | United States |
| Alkermes Investigational Site | Dayton | Ohio | 45417 | United States |
| Alkermes Investigational Site | Austin | Texas | 78754 | United States |
| Alkermes Investigational Site | Austin | Texas | 78759 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75243 | United States |
| Alkermes Investigational Site | DeSoto | Texas | 75115 | United States |
| Alkermes Investigational Site | Houston | Texas | 77030 | United States |
| Alkermes Investigational Site | Bellevue | Washington | 98007 | United States |
| Alkermes Investigational Site | San Juan | 00918 | Puerto Rico |
| Alkermes Investigational Site | San Juan | 00926 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ALKS 3831 | All subjects assigned to ALKS 3831 ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan Oral tablet, daily 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 |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | centimeters |
| ||||||||||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
| ||||||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
| ||||||||||||||||||||||
| Body Mass Index (BMI) Group | Count of Participants | 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 of Subjects With Adverse Events | Overall summary of treatment emergent adverse events during the treatment period | Safety population was defined as all subjects who received at least one dose of the study drug | Posted | Count of Participants | Participants | Up to 52 weeks |
|
|
|
52 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 | All subjects assigned to ALKS 3831 in ALKS 3831-A303 and ALKS 3831-A304 ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan Oral tablet, daily dosing | 0 | 265 | 5 | 265 | 103 | 265 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis alcoholic | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Schizophrenia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Agitation | Psychiatric disorders | Non-systematic Assessment |
| ||
| Psychotic disorder | Psychiatric disorders | Non-systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
| ||
| Extra dose administered | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Weight decreased | Investigations | Non-systematic Assessment |
| ||
| Weight increased | Investigations | Non-systematic Assessment |
| ||
| Blood creatine phosphokinase increased | Investigations | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular 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 | |
|---|---|---|---|---|
| Director, Corporate and R&D Communications | Alkermes | 781-609-7000 | Gretchen.Murphy@alkermes.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 11, 2019 | Jun 10, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| 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 |
|
| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Overweight (>=25 to <30) |
|
| Obese (>=30) |
|
| Title | Measurements |
|---|---|
|
| Severe Treatment- Emergent Adverse Event (TEAE) |
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| Treatment- Emergent Adverse Event (TEAE)-Not Related |
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| Treatment- Emergent Adverse Event (TEAE)-Related |
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| Adverse Event Leading to Treatment Discontinuation |
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| Any Serious Adverse Event (SAE) |
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| Serious Adverse Event (SAE) -Not Related |
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| Serious Adverse Event (SAE)-Related |
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| Serious Adverse Event (SAE) leading to Death |
|