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Sponsor Decision
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This study will assess the long-term safety and tolerability of ALKS 5461 as an adjunctive treatment for refractory MDD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALKS 5461 | Experimental | Sublingual tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALKS 5461 | Drug | samidorphan + buprenorphine administered sublingually |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Number and percentage of subjects experiencing TEAEs | Up to 68 weeks |
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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 | Tucson | Arizona | 85712 | United States | ||
| Alkermes Investigational Site |
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A total of 175 patients were administered at least one dose of ALKS 5461 and included in the safety population.
Subjects that had completed the 12-week treatment period in the antecedent study ALK5461-217 were eligible to be enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | ALKS 5461 | All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually |
| 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 | Nov 14, 2019 | Apr 29, 2021 |
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Open-label
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| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Alkermes Investigational Site | Los Alamitos | California | 90720 | United States |
| Alkermes Investigational Site | Oceanside | California | 92054 | United States |
| Alkermes Investigational Site | Pico Rivera | California | 90660 | United States |
| Alkermes Investigational Site | Redlands | California | 92374 | United States |
| Alkermes Investigational Site | Santa Ana | California | 92705 | United States |
| Alkermes Investigational Site | Sherman Oaks | California | 91403 | United States |
| Alkermes Investigational Site | Temecula | California | 92591 | United States |
| Alkermes Investigational Site | Hollywood | Florida | 33024 | United States |
| Alkermes Investigational Site | Jacksonville | Florida | 32256 | United States |
| Alkermes Investigational Site | Lauderhill | Florida | 33319 | United States |
| Alkermes Investigational Site | Orlando | Florida | 32801 | United States |
| Alkermes Investigational Site | Palm Bay | Florida | 32905 | United States |
| Alkermes Investigational Site | Atlanta | Georgia | 30341 | United States |
| Alkermes Investigational Site | Decatur | Georgia | 30030 | United States |
| Alkermes Investigational Site | Pikesville | Maryland | 21208 | United States |
| Alkermes Investigational Site | O'Fallon | Missouri | 63368 | United States |
| Alkermes Investigational Site | Jamaica | New York | 11432 | United States |
| Alkermes Investigational Site | Mount Kisco | New York | 10549 | United States |
| Alkermes Investigational Site | Canton | Ohio | 44718 | United States |
| Alkermes Investigational Site | Cincinnati | Ohio | 45215 | United States |
| Alkermes Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Alkermes Investigational Site | Allentown | Pennsylvania | 18104 | United States |
| Alkermes Investigational Site | Memphis | Tennessee | 38119 | United States |
| Alkermes Investigational Site | Dallas | Texas | 75390 | United States |
| Alkermes Investigational Site | DeSoto | Texas | 75115 | United States |
| Alkermes Investigational Site | Woodstock | Vermont | 05091 | United States |
| Alkermes Investigational Site | Bellevue | Washington | 98007 | United States |
| Alkermes Investigational Site | Frankston | Victoria | 3199 | Australia |
| Alkermes Investigational Site | Noble Park | Victoria | 3174 | Australia |
| Alkermes Investigational Site | Richmond | Victoria | 3121 | Australia |
| Alkermes Investigational Site | San Juan | 00918 | Puerto Rico |
| Alkermes Investigational Site | San Juan | 00926 | Puerto Rico |
| Completed Treatment |
|
| COMPLETED | Completed study |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ALKS 5461 | All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually |
| 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 |
| ||||||||||||||||||||||
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| 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 | Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | Number and percentage of subjects experiencing TEAEs | Posted | Count of Participants | Participants | Up to 68 weeks |
|
|
|
90 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 5461 | All subjects assigned to ALKS 5461 Sublingual tablets ALKS 5461: samidorphan + buprenorphine administered sublingually | 0 | 175 | 4 | 175 | 85 | 175 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
|
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| 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 | Feb 19, 2020 | Apr 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C000618349 | ALKS 5461 |
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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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| Puerto Rico |
|