Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate weight gain of ALKS 3831 compared to olanzapine in adult subjects with schizophrenia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 3831 | Experimental | Administered as a coated bilayer tablet |
|
| Olanzapine | Active Comparator | Administered as a coated bilayer tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 3831 | Drug | Daily dosing |
| |
| Olanzapine |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Body Weight at Week 24 | Baseline and Week 24 | |
| Percentage of Participants With >/= 10% Weight Gain at Week 24 | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With >/= 7% Weight Gain at Week 24 | Baseline and Week 24 | |
| Number of Participants Experiencing of Adverse Events (AEs) | 24 weeks |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|
| 36305696 | Derived | Correll CU, Stein E, Graham C, DiPetrillo L, Akerman S, Stanford AD, Jiang Y, Yagoda S, McDonnell D, Hopkinson C. Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study. Schizophr Bull. 2023 Mar 15;49(2):454-463. doi: 10.1093/schbul/sbac144. | |
| 36226902 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Olanzapine | Administered as a coated bilayer tablet Olanzapine: Daily dosing |
| FG001 | ALKS 3831 | Administered as a coated bilayer tablet ALKS 3831: Daily dosing |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2018 | Oct 9, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Daily dosing |
|
| 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 | Long Beach | California | 90822 | United States |
| Alkermes Investigational Site | National City | California | 91950 | 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 | Washington D.C. | District of Columbia | 20016 | United States |
| Alkermes Investigational Site | Lauderhill | Florida | 33319 | United States |
| Alkermes Investigational Site | Miami | Florida | 33136 | United States |
| Alkermes Investigational Site | North Miami | Florida | 33161 | United States |
| Alkermes Investigational Site | Oakland Park | Florida | 33334 | United States |
| Alkermes Investigational Site | Tampa | Florida | 33609 | 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 | O'Fallon | Missouri | 63368 | 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 | New York | New York | 10032 | United States |
| Alkermes Investigational Site | New York | New York | 10035 | United States |
| Alkermes Investigational Site | Rochester | New York | 14615 | United States |
| Alkermes Investigational Site | Wards Island | New York | 10035 | United States |
| Alkermes Investigational Site | Canton | Ohio | 44718 | United States |
| Alkermes Investigational Site | Dayton | Ohio | 45417 | United States |
| Alkermes Investigational Site | Middleburg Heights | Ohio | 44130 | United States |
| Alkermes Investigational Site | Allentown | Pennsylvania | 18104 | 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 | PR | 00918 | Puerto Rico |
| Alkermes Investigational Site | San Juan | PR | 00926 | Puerto Rico |
| Meyer JM, Simmons A, Jiang Y, Graham C, Yagoda S, McDonnell D. Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients. CNS Spectr. 2023 Aug;28(4):478-481. doi: 10.1017/S1092852922000967. Epub 2022 Oct 13. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Disposition is shown for the safety population - subjects who were randomized and received at least 1 dose of study drug. 5 subject in the olanzapine group and 6 subject in the ALKS 3831 group were randomized but not treated, and thus were not included in the safety population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Olanzapine | Administered as a coated bilayer tablet Olanzapine: Daily dosing |
| BG001 | ALKS 3831 | Administered as a coated bilayer tablet ALKS 3831: Daily dosing |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | 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 | Percent Change From Baseline in Body Weight at Week 24 | The full analysis set (FAS) population includes all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment | Posted | Least Squares Mean | Standard Error | Percent change in body weight | Baseline and Week 24 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With >/= 10% Weight Gain at Week 24 | The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment. | Posted | Number | Percentage of participants | Baseline and Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With >/= 7% Weight Gain at Week 24 | The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment. | Posted | Number | Percentage of participants | Baseline and Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Experiencing of Adverse Events (AEs) | The Safety Population includes all randomized subjects who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | 24 weeks |
|
|
Up to 24 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olanzapine | Administered as a coated bilayer tablet Olanzapine: Daily dosing | 0 | 276 | 7 | 276 | 159 | 276 |
| EG001 | ALKS 3831 | Administered as a coated bilayer tablet ALKS 3831: Daily dosing | 0 | 274 | 10 | 274 | 146 | 274 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Cellulitis staphylococcal | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Infectious colitis | Infections and infestations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Substance-induced psychotic disorder | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Extra dose administered | Injury, poisoning and procedural complications | MedDRA (21.0) | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Waist circumference increased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (21.0) | Non-systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (21.0) | 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 | |
|---|---|---|---|---|
| Eva Stroynowski | Alkermes | 781-609-7000 | Eva.Stroynowski@alkermes.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 18, 2018 | Oct 9, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001835 | Body Weight |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077152 | Olanzapine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|