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
Not provided
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.
The study consisted of 2 parts, Part A and Part B. Part A was a double-blind, placebo-controlled assessment of safety and efficacy of VIVITROL versus placebo for 3 months. Part B was an open-label extension to assess longer-term safety, durability of effect, and health economics of VIVITROL when administered for up to 9 additional months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIVITROL 380 mg | Active Comparator | Administered via intramuscular (IM) injection once every 4 weeks. |
|
| Placebo for VIVITROL 380 mg | Placebo Comparator | Administered via IM injection once every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIVITROL 380 mg | Drug | Administered via IM injection once every 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Percentage of Participants by Heavy Drinking Rate | Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A "heavy drinking day" was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell & Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary). | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Longer-term Safety of VIVITROL | Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study. | up to 1 year |
Not provided
Primary Inclusion Criteria:
Primary Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bernard L. Silverman, MD | Alkermes, Inc. | Study Director |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | VIVITROL 380 mg | Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site. |
| FG001 | Placebo for VIVITROL 380 mg | All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part A (Double-blind Period) |
| |||||||||||||
| Part B (Open-label Period) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | VIVITROL 380 mg | Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site. |
| BG001 |
| 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 | Cumulative Percentage of Participants by Heavy Drinking Rate | Cumulative percentage (%) of subjects reporting heavy drinking by category reflecting the various cut-offs for percentage of days that were heavy drinking days. A "heavy drinking day" was defined as 4 or more alcohol drinks in 1 day for women, and 5 or more alcohol drinks in 1 day for men. The Timeline Follow-Back (TLFB) method (Sobell & Sobell: Humana Press, 1992) was utilized to collect subjects' daily drinking information (ie, the number of drinks consumed per day per subject which was retrospectively recalled and recorded in a diary). | The primary endpoint is based on percentage rate of heavy drinking days during the double-blind treatment period as per protocol. | Posted | Mar 2011 | Number | percentage of participants | up to 12 weeks |
|
AE collection began after a subject signed the informed consent form and continued until 30 days after the last dose of study drug was administered.
All volunteered, elicited, and observed AEs were recorded on the AE CRFs.
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 | VIVITROL 380 mg (Double-blind Period) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcoholism | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site pain | General disorders | MedDRA (10.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bernard L. Silverman, MD | Alkermes, Inc. | 1-781-609-6000 | bernard.silverman@alkermes.com |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C000624616 | vivitrol |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo for VIVITROL 380 mg | Drug | Administered via IM injection once every 4 weeks. |
|
| NOT COMPLETED |
|
| Placebo for VIVITROL 380 mg |
All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site. |
| 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 |
|
| Placebo |
|
|
|
| Secondary | Longer-term Safety of VIVITROL | Number of subjects reporting at least 1 treatment-emergent adverse event (TEAE) while on study. | Not Posted | Number | participants | up to 1 year |
| 29 |
| 152 |
| 135 |
| 152 |
| EG001 | Placebo for VIVITROL 380 mg (Double-blind Period) | 27 | 148 | 133 | 148 |
| Suicidal ideation | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Adjustment disorder | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Bereavement reaction | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Bipolar disorder | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Emotional distress | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Psychosomatic disease | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Somnolence | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Inflammation | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Injection site abscess | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Erysipelas | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
|
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
|
| Gynaecomastia | Reproductive system and breast disorders | MedDRA (10.1) | Systematic Assessment |
|
| Tibia fracture | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Alcoholic seizure | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Alcohol detoxification | Surgical and medical procedures | MedDRA (10.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (10.1) | Systematic Assessment |
|
| Alcoholism | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA (10.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.1) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
|
No individual Investigator may publish results without written agreement from Alkermes. Should an Investigator wish to publish or present the data at a meeting, a copy of the manuscript or abstract must be provided to the Sponsor at least 30 days prior to the submission for review and approval. Any revisions will be negotiated in good faith by the Investigator and Sponsor.
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| 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 |