Trial Outcomes & Findings for ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997]) (NCT NCT00156936)

Last Updated: 2010-11-17

Results Overview

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 through the end of the follow-up period).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

108 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2010-11-17

Participant Flow

Recruitment was conducted at 17 clinical trial study centers in the United States.

Investigators ensured subjects were opioid-free (ie, had opioid-free urine screening results) prior to initiation of study therapy. For subjects diagnosed with opioid dependence or in whom clinically significant opioid use was suspected, a naloxone challenge test was performed.

Participant milestones

Participant milestones
Measure	Medisorb Naltrexone 380 mg (VIVITROL) Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.	Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL) Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
Overall Study STARTED	92	16
Overall Study COMPLETED	20	5
Overall Study NOT COMPLETED	72	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medisorb Naltrexone 380 mg (VIVITROL) n=92 Participants Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.	Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL) n=16 Participants Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.	Total n=108 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=5 Participants	16 Participants n=7 Participants	108 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	42.3 years STANDARD_DEVIATION 10.0 • n=5 Participants	45.3 years STANDARD_DEVIATION 11.5 • n=7 Participants	42.7 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	5 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	11 Participants n=7 Participants	73 Participants n=5 Participants
Region of Enrollment United States	92 participants n=5 Participants	16 participants n=7 Participants	108 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: Safety population includes all enrolled subjects who received at least 1 dose of study drug (VIVITROL 380 mg) in this extension study.

Outcome measures

Outcome measures
Measure	Medisorb Naltrexone 380 mg (VIVITROL) n=62 Participants Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.	Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL) n=11 Participants Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
Number of Subjects Who Reported at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study.	62 Participants	11 Participants

Adverse Events

Medisorb Naltrexone 380 mg (VIVITROL)

Serious events: 9 serious events

Other events: 62 other events

Deaths: 0 deaths

Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Medisorb Naltrexone 380 mg (VIVITROL) n=92 participants at risk Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.	Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL) n=16 participants at risk Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
Psychiatric disorders Alcohol dependence syndrome	1.1% 1/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Musculoskeletal and connective tissue disorders Aseptic necrosis bone	0.00% 0/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	6.2% 1/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Infections and infestations Bronchitis acute NOS	1.1% 1/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchospasm NOS	1.1% 1/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
General disorders Chest pain	0.00% 0/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	6.2% 1/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Nervous system disorders Convulsions NOS	1.1% 1/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Gastrointestinal disorders Oesophageal ulcer haemorrhage	0.00% 0/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	6.2% 1/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Overdose NOS	2.2% 2/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Infections and infestations Pneumonia bacterial NOS	1.1% 1/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Infections and infestations Pneumonia streptococcal	1.1% 1/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure (excl. neonatal)	1.1% 1/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Infections and infestations Staphylococcal infection NOS	1.1% 1/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Psychiatric disorders Suicidal ideation	1.1% 1/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.
Injury, poisoning and procedural complications Road traffic accident	1.1% 1/92 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.	0.00% 0/16 • Up to approximately 3 years Safety parameters, including assessment for adverse events (AEs), were conducted at each study visit. All AE reports, whether volunteered, elicited, or observed, were recorded on the appropriate case report forms (CRFs). The recording of AEs began from the time of study enrollment until 30 days after the last dose of study drug.

Other adverse events

Additional Information

Bernard L. Silverman / VP, Clinical Development

Alkermes, Inc.

Phone: 781-609-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER