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This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 [the base study]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.
All participants in this study received Medisorb naltrexone at double-blinded dose strengths (ie, 190 mg or 380 mg); no participant received placebo. Participants who had received Medisorb naltrexone in Study ALK21-003 (NCT01218958) continued to receive the same dose strength in this extension study. Those who had received placebo for Medisorb naltrexone 190 mg in the base study were given Medisorb naltrexone 190 mg. Participants who had received placebo for Medisorb naltrexone 380 mg in the base study were given Medisorb naltrexone 380 mg.
Neither the identity or dose of the treatment received in the base study, nor the Medisorb naltrexone dose strength (190 mg or 380 mg) received in this extension were revealed to any participant, the investigator, or any blinded member of the clinical study team during the conduct of the base study or this extension.
All participants were encouraged to receive standardized biopsychosocial support at each clinic visit throughout the study; however, unlike the base study, participation was not mandatory.
Participants eligible for this extension study had received all 6 injections of study drug in the base study; those who received Medisorb naltrexone in the base study who also received all 13 injections in this extension therefore had a duration of exposure of approximately 76 weeks (~1.5 years) upon completion of this extension. For participants who had received placebo in the base study, maximum duration of exposure was approx. 48 weeks (1 year).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medisorb naltrexone 380 mg | Experimental | Intramuscular (IM) injection administered once every 4 weeks for up to 48 weeks. |
|
| Medisorb naltrexone 190 mg | Experimental | IM injection administered once every 4 weeks for up to 48 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medisorb naltrexone 190 mg | Drug | naltrexone for extended-release injectable suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study | A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period). | Up to 48 weeks (13 injections), not including base study |
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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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| ID | Title | Description |
|---|---|---|
| FG000 | Medisorb Naltrexone 380 mg | |
| FG001 | Medisorb Naltrexone 190 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medisorb Naltrexone 380 mg | |
| BG001 | Medisorb Naltrexone 190 mg | |
| BG002 | Total |
| 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) While in Study | A TEAE is any adverse event, whether or not considered drug-related, that develops or worsens in severity after study drug administration begins (ie, from the first administration through the end of the follow-up period). | All participants who received at least 1 dose of study drug are included in the safety population. | Posted | Number | Participants | Up to 48 weeks (13 injections), not including base study |
|
1 year (Baseline to Week 52)
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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 380mg--Combined | Includes all participants who received Medisorb naltrexone 380mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral disc degeneration NOS | Musculoskeletal and connective tissue disorders | MedDRA (4.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (4.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernard L. Silverman, MD | Alkermes, Inc. | 781-609-6000 | bernard.silverman@alkermes.com |
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| 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 |
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| Medisorb naltrexone 380 mg | Drug | naltrexone for extended-release injectable suspension |
|
|
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 6 |
| 175 |
| 143 |
| 175 |
| EG001 | Medisorb Naltrexone 190mg--Combined | Includes all participants who received Medisorb naltrexone 190mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks. | 12 | 157 | 130 | 157 |
| EG002 | Placebo to 380mg | Includes participants who received placebo in the base study but switched to Medisorb naltrexone 380mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks. | 2 | 60 | 51 | 60 |
| EG003 | 380mg to 380mg | Includes participants who received Medisorb naltrexone 380mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks. | 4 | 115 | 92 | 115 |
| EG004 | Placebo to 190mg | Includes participants who received placebo in the base study but switched to Medisorb naltrexone 190mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks. | 2 | 55 | 46 | 55 |
| EG005 | 190mg to 190mg | includes participants who received Medisorb naltrexone 190mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks. | 10 | 102 | 84 | 102 |
| Drug abuser NOS | Social circumstances | MedDRA (4.1) | Systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA (4.1) | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA (4.1) | Systematic Assessment |
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| Abdominal pain NOS | Gastrointestinal disorders | MedDRA (4.1) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (4.1) | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (4.1) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (4.1) | Systematic Assessment |
|
| Cholecystitis acute NOS | Hepatobiliary disorders | MedDRA (4.1) | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA (4.1) | Systematic Assessment |
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| Hepatitis acute | Hepatobiliary disorders | MedDRA (4.1) | Systematic Assessment |
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| Pneumonia NOS | Infections and infestations | MedDRA (4.1) | Systematic Assessment |
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| Limb injury NOS | Injury, poisoning and procedural complications | MedDRA (4.1) | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (4.1) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA (4.1) | Systematic Assessment |
|
| Pancreatic carcinoma NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (4.1) | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA (4.1) | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA (4.1) | Systematic Assessment |
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| Upper respiratory tract infection NOS | Infections and infestations | MedDRA (4.1) | Systematic Assessment |
|
| Sinusitis NOS | Infections and infestations | MedDRA (4.1) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (4.1) | Systematic Assessment |
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| Bronchitis NOS | Infections and infestations | MedDRA (4.1) | Systematic Assessment |
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| Gastroenteritis viral NOS | Infections and infestations | MedDRA (4.1) | Systematic Assessment |
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| Injection site induration | General disorders | MedDRA (4.1) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (4.1) | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA (4.1) | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA (4.1) | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (4.1) | Systematic Assessment |
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| Pain in limb | Musculoskeletal and connective tissue disorders | MedDRA (4.1) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (4.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (4.1) | Systematic Assessment |
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| Vomiting NOS | Gastrointestinal disorders | MedDRA (4.1) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (4.1) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (4.1) | Systematic Assessment |
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| Anxiety NEC | Psychiatric disorders | MedDRA (4.1) | Systematic Assessment |
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| Alcoholism | Psychiatric disorders | MedDRA (4.1) | Systematic Assessment |
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| Headache NOS | Nervous system disorders | MedDRA (4.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (4.1) | Systematic Assessment |
|
| Back injury NOS | Injury, poisoning and procedural complications | MedDRA (4.1) | Systematic Assessment |
|
| Rash NOS | Skin and subcutaneous tissue disorders | MedDRA (4.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (4.1) | Systematic Assessment |
|
| Appetite decreased NOS | Metabolism and nutrition disorders | MedDRA (4.1) | Systematic Assessment |
|
| Seasonal allergy | Immune system 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 prior to the submission, for review and approval. Revisions will be negotiated in good faith by the Investigator and Sponsor and may be submitted for publication or disclosed by the Investigator only following receipt of written approval from the Sponsor.