Trial Outcomes & Findings for ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults (NCT NCT00156923)

Last Updated: 2017-07-11

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 in this extension through the end of the follow-up period).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

108 participants

Primary outcome timeframe

Up to 3.5 years of monthly treatment

Results posted on

2017-07-11

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Medisorb Naltrexone 380 mg Administered via intramuscular (IM) injection once every 4 weeks.	Medisorb Naltrexone 190 mg Administered via IM injection once every 4 weeks.
Overall Study STARTED	56	52
Overall Study COMPLETED	22	20
Overall Study NOT COMPLETED	34	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Medisorb Naltrexone 380 mg n=56 Participants Administered via intramuscular (IM) injection once every 4 weeks.	Medisorb Naltrexone 190 mg n=52 Participants Administered via IM injection once every 4 weeks.	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	53 Participants n=5 Participants	47 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age, Continuous	45.9 years STANDARD_DEVIATION 9.0 • n=5 Participants	48.1 years STANDARD_DEVIATION 10.0 • n=7 Participants	46.9 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	32 Participants n=7 Participants	69 Participants n=5 Participants
Region of Enrollment United States	56 participants n=5 Participants	52 participants n=7 Participants	108 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3.5 years of monthly treatment

Population: Subjects who received at least 1 injection of study drug were included in the safety analyses

Outcome measures

Outcome measures
Measure	Medisorb Naltrexone 380 mg n=56 Participants Administered via intramuscular (IM) injection once every 4 weeks.	Medisorb Naltrexone 190 mg n=52 Participants Administered via IM injection once every 4 weeks.
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)	49 Participants	51 Participants

Adverse Events

Medisorb Naltrexone 380 mg

Serious events: 9 serious events

Other events: 51 other events

Deaths: 0 deaths

Medisorb Naltrexone 190 mg

Serious events: 9 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

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

Measure	Medisorb Naltrexone 380 mg n=56 participants at risk Administered via intramuscular (IM) injection once every 4 weeks.	Medisorb Naltrexone 190 mg n=52 participants at risk Administered via IM injection once every 4 weeks.
Psychiatric disorders Alcoholism	5.4% 3/56 • 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.	0.00% 0/52 • 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.
Psychiatric disorders Completed suicide	0.00% 0/56 • 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.	1.9% 1/52 • 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.
Psychiatric disorders Confusion	0.00% 0/56 • 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.	1.9% 1/52 • 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.
Psychiatric disorders Psychotic disorder NOS	1.8% 1/56 • 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.	0.00% 0/52 • 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.
Psychiatric disorders Suicidal ideation	0.00% 0/56 • 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.	1.9% 1/52 • 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.
Cardiac disorders Atrial fibrillation	0.00% 0/56 • 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.	1.9% 1/52 • 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.
Cardiac disorders Coronary artery disease NOS	1.8% 1/56 • 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.	1.9% 1/52 • 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.
Gastrointestinal disorders Abdominal pain	1.8% 1/56 • 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.	0.00% 0/52 • 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.
General disorders Chest pain	3.6% 2/56 • 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.	0.00% 0/52 • 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.
Infections and infestations Bronchitis NOS	1.8% 1/56 • 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.	0.00% 0/52 • 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.
Infections and infestations Cellulitis	0.00% 0/56 • 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.	1.9% 1/52 • 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.
Infections and infestations Meningitis viral NOS	0.00% 0/56 • 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.	1.9% 1/52 • 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.
Injury, poisoning and procedural complications Forearm fracture	1.8% 1/56 • 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.	0.00% 0/52 • 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.
Musculoskeletal and connective tissue disorders Tenosynovitis	0.00% 0/56 • 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.	1.9% 1/52 • 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.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer NOS	1.8% 1/56 • 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.	0.00% 0/52 • 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.
Nervous system disorders Cerebral arterial aneurysm	1.8% 1/56 • 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.	0.00% 0/52 • 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.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/56 • 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.	1.9% 1/52 • 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.
Social circumstances Drug abuser NOS	0.00% 0/56 • 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.	1.9% 1/52 • 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.
Surgical and medical procedures Gastric operation NOS	1.8% 1/56 • 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.	0.00% 0/52 • 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.
Vascular disorders Deep venous thrombosis NOS	0.00% 0/56 • 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.	3.8% 2/52 • 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.
Vascular disorders Pulmonary embolism	0.00% 0/56 • 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.	1.9% 1/52 • 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.