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

• Sponsor: Alkermes, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00156923
• Collaborator: (none)
• Enrollment: 108
• Arms: 2
• Duration (Months): 39

Study Details

Study Description

Brief Summary

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®).

Condition or Disease	Intervention/Treatment	Phase
Alcoholism	Drug: Medisorb naltrexone 380 mg; Drug: Medisorb naltrexone 190 mg	Phase 3

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone
• Study Start Date: Oct 1, 2003
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Medisorb naltrexone 380 mg	Drug: Medisorb naltrexone 380 mg; Administered via intramuscular (IM) injection once every 4 weeks for up to 3.5 years.; Other Names: VIVITROL® 380 mg Naltrexone for extended-release injectable suspension
Experimental: Medisorb naltrexone 190 mg	Drug: Medisorb naltrexone 190 mg; Administered via IM injection once every 4 weeks for up to 3.5 years.; Other Names: Naltrexone for extended-release injectable suspension

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) [Up to 3.5 years of monthly treatment]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Primary Inclusion Criteria:

• Completed Study ALK21-003-EXT (NCT01218971), receiving all 13 injections

• Willing and able to return for scheduled clinic visits and study assessments

• Noncustodial, stable address and phone

• Written, informed consent

Primary Exclusion Criteria:

• Pregnancy or lactation

• Terminated early from study drug in Study ALK21-003-EXT (NCT01218971)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alkermes, Inc.

Investigators

• Study Director: Bernard L. Silverman, MD, Alkermes, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• WHO International Clinical Trials registry platform search portal

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00156923
• Other Study ID Numbers: ALK21-010
• First Posted: Sep 12, 2005
• Last Update Posted: Jul 11, 2017
• Last Verified: Jun 1, 2017

• Keywords provided by , ,: Alcohol dependence
• Additional relevant MeSH terms: Alcoholism; Naltrexone

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Medisorb Naltrexone 380 mg	Medisorb Naltrexone 190 mg
Arm/Group Description	Administered via intramuscular (IM) injection once every 4 weeks.	Administered via IM injection once every 4 weeks.
Period Title: Overall Study
STARTED	56	52
COMPLETED	22	20
NOT COMPLETED	34	32

Baseline Characteristics

Arm/Group Title	Medisorb Naltrexone 380 mg	Medisorb Naltrexone 190 mg	Total
Arm/Group Description	Administered via intramuscular (IM) injection once every 4 weeks.	Administered via IM injection once every 4 weeks.	Total of all reporting groups
Overall Participants	56	52	108
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	53 94.6%	47 90.4%	100 92.6%
>=65 years	3 5.4%	5 9.6%	8 7.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.9 (9.0)	48.1 (10.0)	46.9 (9.5)
Sex: Female, Male (Count of Participants)
Female	19 33.9%	20 38.5%	39 36.1%
Male	37 66.1%	32 61.5%	69 63.9%
Region of Enrollment (participants) [Number]
United States	56 100%	52 100%	108 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE)
Description	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).
Time Frame	Up to 3.5 years of monthly treatment

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Medisorb Naltrexone 380 mg	Medisorb Naltrexone 190 mg
Arm/Group Description	Administered via intramuscular (IM) injection once every 4 weeks.	Administered via IM injection once every 4 weeks.
Measure Participants	56	52
Number [Participants]	49 87.5%	51 98.1%

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	AEs were summarized according to number of subjects affected as opposed to number of incidences reported for any one preferred term.
Arm/Group Title	Medisorb Naltrexone 380 mg		Medisorb Naltrexone 190 mg
Arm/Group Description	Administered via intramuscular (IM) injection once every 4 weeks.		Administered via IM injection once every 4 weeks.
All Cause Mortality
	Medisorb Naltrexone 380 mg		Medisorb Naltrexone 190 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Medisorb Naltrexone 380 mg		Medisorb Naltrexone 190 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/56 (16.1%)		9/52 (17.3%)
Cardiac disorders
Atrial fibrillation	0/56 (0%)		1/52 (1.9%)
Coronary artery disease NOS	1/56 (1.8%)		1/52 (1.9%)
Gastrointestinal disorders
Abdominal pain	1/56 (1.8%)		0/52 (0%)
General disorders
Chest pain	2/56 (3.6%)		0/52 (0%)
Infections and infestations
Bronchitis NOS	1/56 (1.8%)		0/52 (0%)
Cellulitis	0/56 (0%)		1/52 (1.9%)
Meningitis viral NOS	0/56 (0%)		1/52 (1.9%)
Injury, poisoning and procedural complications
Forearm fracture	1/56 (1.8%)		0/52 (0%)
Musculoskeletal and connective tissue disorders
Tenosynovitis	0/56 (0%)		1/52 (1.9%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer NOS	1/56 (1.8%)		0/52 (0%)
Nervous system disorders
Cerebral arterial aneurysm	1/56 (1.8%)		0/52 (0%)
Psychiatric disorders
Alcoholism	3/56 (5.4%)		0/52 (0%)
Completed suicide	0/56 (0%)		1/52 (1.9%)
Confusion	0/56 (0%)		1/52 (1.9%)
Psychotic disorder NOS	1/56 (1.8%)		0/52 (0%)
Suicidal ideation	0/56 (0%)		1/52 (1.9%)
Respiratory, thoracic and mediastinal disorders
Emphysema	0/56 (0%)		1/52 (1.9%)
Social circumstances
Drug abuser NOS	0/56 (0%)		1/52 (1.9%)
Surgical and medical procedures
Gastric operation NOS	1/56 (1.8%)		0/52 (0%)
Vascular disorders
Deep venous thrombosis NOS	0/56 (0%)		2/52 (3.8%)
Pulmonary embolism	0/56 (0%)		1/52 (1.9%)
Other (Not Including Serious) Adverse Events
	Medisorb Naltrexone 380 mg		Medisorb Naltrexone 190 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	51/56 (91.1%)		49/52 (94.2%)
Gastrointestinal disorders
Toothache	5/56 (8.9%)		5/52 (9.6%)
Dyspepsia	3/56 (5.4%)		2/52 (3.8%)
Diarrhoea NOS	3/56 (5.4%)		2/52 (3.8%)
Nausea	3/56 (5.4%)		4/52 (7.7%)
Vomiting	3/56 (5.4%)		2/52 (3.8%)
General disorders
Fatigue	4/56 (7.1%)		6/52 (11.5%)
Fall	3/56 (5.4%)		2/52 (3.8%)
Immune system disorders
Seasonal allergy	4/56 (7.1%)		1/52 (1.9%)
Infections and infestations
Upper respiratory tract infection NOS	13/56 (23.2%)		11/52 (21.2%)
Influenza	6/56 (10.7%)		3/52 (5.8%)
Nasopharyngitis	6/56 (10.7%)		9/52 (17.3%)
Cold symptoms	2/56 (3.6%)		6/52 (11.5%)
Gastroenteritis viral NOS	3/56 (5.4%)		4/52 (7.7%)
Metabolism and nutrition disorders
Hypercholesterolaemia	2/56 (3.6%)		4/52 (7.7%)
Musculoskeletal and connective tissue disorders
Arthralgia	7/56 (12.5%)		7/52 (13.5%)
Nervous system disorders
Headache NOS	4/56 (7.1%)		6/52 (11.5%)
Dizziness	3/56 (5.4%)		2/52 (3.8%)
Psychiatric disorders
Alcoholism	3/56 (5.4%)		2/52 (3.8%)
Anxiety NEC	3/56 (5.4%)		2/52 (3.8%)
Insomnia	4/56 (7.1%)		7/52 (13.5%)
Depression	6/56 (10.7%)		6/52 (11.5%)
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain	1/56 (1.8%)		4/52 (7.7%)
Skin and subcutaneous tissue disorders
Rash NOS	3/56 (5.4%)		2/52 (3.8%)
Vascular disorders
Hypertension NOS	3/56 (5.4%)		6/52 (11.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.