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This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).
Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medisorb naltrexone 380 mg | Experimental |
| |
| Medisorb naltrexone 190 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medisorb naltrexone 380 mg | Drug | Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period). | Up to 3.5 years of monthly treatment |
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard L. Silverman, MD | Alkermes, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21314752 | Result | O'Brien CP, Gastfriend DR, Forman RF, Schweizer E, Pettinati HM. Long-term opioid blockade and hedonic response: preliminary data from two open-label extension studies with extended-release naltrexone. Am J Addict. 2011 Mar-Apr;20(2):106-12. doi: 10.1111/j.1521-0391.2010.00107.x. Epub 2010 Dec 28. |
| Label | URL |
|---|---|
| WHO International Clinical Trials registry platform search portal | View source |
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Subjects who successfully completed Alkermes' Study ALK21-003EXT (NCT01218971) and who continued to meet eligibility criteria were given the option to enroll into this extension study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Medisorb Naltrexone 380 mg | Administered via intramuscular (IM) injection once every 4 weeks. |
| FG001 | Medisorb Naltrexone 190 mg | Administered via IM injection once every 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medisorb Naltrexone 380 mg | Administered via intramuscular (IM) injection once every 4 weeks. |
| BG001 | Medisorb Naltrexone 190 mg | Administered via IM injection once every 4 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) | A TEAE is any adverse event (AE), whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration in this extension through the end of the follow-up period). | Subjects who received at least 1 injection of study drug were included in the safety analyses | Posted | Number | Participants | Up to 3.5 years of monthly treatment |
|
Not including the base study (Study ALK21-003 [NCT01218958]) or the first extension (Study ALK21-003EXT [NCT01218971]), the maximum exposure to study drug and safety monitoring in subjects completing this second extension was approximately 3.5 years.
AEs were summarized according to number of subjects affected as opposed to number of incidences reported for any one preferred term.
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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 | Medisorb Naltrexone 380 mg | Administered via intramuscular (IM) injection once every 4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcoholism | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection NOS | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernard L. Silverman / VP, Clinical Development | Alkermes, Inc. | 781-609-6000 | bernard.silverman@alkermes.com |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Medisorb naltrexone 190 mg | Drug | Administered via IM injection once every 4 weeks for up to 3.5 years. |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Administered via IM injection once every 4 weeks.
|
|
| 9 |
| 56 |
| 51 |
| 56 |
| EG001 | Medisorb Naltrexone 190 mg | Administered via IM injection once every 4 weeks. | 9 | 52 | 49 | 52 |
| Completed suicide | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Confusion | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Psychotic disorder NOS | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 4.1 | Systematic Assessment |
|
| Coronary artery disease NOS | Cardiac disorders | MedDRA 4.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Bronchitis NOS | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Meningitis viral NOS | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Forearm fracture | Injury, poisoning and procedural complications | MedDRA 4.1 | Systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Breast cancer NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 4.1 | Systematic Assessment |
|
| Cerebral arterial aneurysm | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Drug abuser NOS | Social circumstances | MedDRA 4.1 | Systematic Assessment |
|
| Gastric operation NOS | Surgical and medical procedures | MedDRA 4.1 | Systematic Assessment |
|
| Deep venous thrombosis NOS | Vascular disorders | MedDRA 4.1 | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | MedDRA 4.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Cold symptoms | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Gastroenteritis viral NOS | Infections and infestations | MedDRA 4.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Rash NOS | Skin and subcutaneous tissue disorders | MedDRA 4.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Diarrhoea NOS | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 4.1 | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Anxiety NEC | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 4.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Fall | General disorders | MedDRA 4.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 4.1 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Headache NOS | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 4.1 | Systematic Assessment |
|
| Hypertension NOS | Vascular disorders | MedDRA 4.1 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 4.1 | Systematic Assessment |
|
Should a PI wish to disclose results, the sponsor will review the results communications prior to public release and can embargo results communications for a period of at least 30 days but less than or equal to 90 days from the time submitted to the sponsor for review. Revisions will be negotiated in good faith. For a multicenter study the institution/PI agree to publish/publicly present the results together with the other sites unless the sponsor grants written permission in advance.
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |