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
The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 3831 | Experimental | Olanzapine + samidorphan; administered as a coated bilayer tablet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 3831 | Drug | Tablets were administered for daily dosing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 52 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion 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 |
|---|---|---|---|
| 41944743 | Derived | McIntyre RS, Matthews DM, Arevalo C, McDonnell D, Correll CU. The Efficacy of Olanzapine/Samidorphan on Negative Symptoms: A Post Hoc Analysis of 56-Week Treatment in Patients With Schizophrenia. J Clin Psychiatry. 2026 Mar 9;87(2):25m16170. doi: 10.4088/JCP.25m16170. |
Not provided
Not provided
A total of 4 subjects enrolled but were not dosed. Three subjects were lost-to-follow-up prior to receiving study drug, and one subject was not compliant with study drug. A total of 277 patients were administered at least one dose of ALKS 3831 and were included in the safety population.
Subjects who completed the 4-week treatment period of the antecedent study, ALK3831-A305, were eligible to be enrolled in Study ALK3831-A306 within 7 days of their last study visit in ALK3831-A305.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 | Apr 25, 2017 | Jun 12, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Springdale |
| Arkansas |
| 72764 |
| 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 | Orange | California | 92868 | United States |
| Alkermes Investigational Site | San Diego | California | 92103 | United States |
| Alkermes Investigational Site | Miami | Florida | 33161 | United States |
| Alkermes Investigational Site | Chicago | Illinois | 60640 | United States |
| Alkermes Investigational Site | St Louis | Missouri | 63141 | United States |
| Alkermes Investigational Site | Las Vegas | Nevada | 89102 | United States |
| Alkermes Investigational Site | Marlton | New Jersey | 08053 | United States |
| Alkermes Investigational Site | Dayton | Ohio | 45417 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75243 | United States |
| Alkermes Investigational Site | Burgas | Bulgaria |
| Alkermes Investigational Site | Kazanlak | 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 | Belgrade | Serbia |
| Alkermes Investigational Site | Kragujevac | Serbia |
| Alkermes Investigational Site | Novi Kneževac | Serbia |
| Alkermes Investigational Site | Kharkiv | Ukraine |
| Alkermes Investigational Site | Kiev | Ukraine |
| Alkermes Investigational Site | Lviv | Ukraine |
| Alkermes Investigational Site | Stepanovka | Ukraine |
| Alkermes Investigational Site | Vinnytsia | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Population includes all subjects who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ALKS 3831 | Administered as a coated bilayer tablet. ALKS 3831: 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 |
| |||||||||||||||||||||||
| Region of Enrollment | Number | Count of 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 Participants With Adverse Events (AEs) | Safety population includes all subjects who received at least one dose of study drug. | Posted | Count of Participants | Participants | Up to 52 weeks |
|
|
|
Up to 52 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 | ALKS 3831 | Administered as a coated bilayer tablet. ALKS 3831: Daily dosing | 0 | 277 | 8 | 277 | 102 | 277 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Schizophrenia | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weight increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Blood insulin increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Blood prolactin increased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Extra dose administered | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment | Resulted from the errors made by the subjects or caregivers while taking the study medication |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Social stay hospitalisation | Social circumstances | MedDRA (19.0) | Non-systematic Assessment | Per protocol social stay hospitalizations were not considered Serious Adverse Events, and were recorded as AEs |
|
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 | Oct 5, 2017 | Jun 12, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Bulgaria |
|
| Serbia |
|