Trial · NCT01218971

ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)

NCT01218971, Phase 3, Completed, Alkermes, Inc.; results first posted 2010-12-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®). Trials, record NCT01218971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01218971

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ALK21-003EXT: An Extension of Study ALK21-003 (NCT01218958) to Test the Long-term Safety of Medisorb® Naltrexone (VIVITROL®)
NCT number: NCT01218971
Status: Completed
Phases: Phase 3
Enrollment: 332 participants, actual
Lead sponsor: Alkermes, Inc.
Conditions: Alcohol Dependence
Interventions: Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg
First posted: 2010-10-13
Last updated: 2010-12-24
Results first posted: 2010-12-08

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study	Up to 48 weeks (13 injections), not including base 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).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study	Up to 48 weeks (13 injections), not including base study	All participants who received at least 1 dose of study drug are included in the safety population.	Participants	NUMBER

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study	Medisorb Naltrexone 380 mg		143		Participants
Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study	Medisorb Naltrexone 190 mg		130		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Medisorb Naltrexone 380 mg	175
Overall Study	STARTED	Medisorb Naltrexone 190 mg	157
Overall Study	COMPLETED	Medisorb Naltrexone 380 mg	71
Overall Study	COMPLETED	Medisorb Naltrexone 190 mg	77
Overall Study	NOT COMPLETED	Medisorb Naltrexone 380 mg	104
Overall Study	NOT COMPLETED	Medisorb Naltrexone 190 mg	80

Source ClinicalTrials.gov

Adverse events264

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Medisorb Naltrexone 380mg--Combined	16	175
other	Nasopharyngitis	Infections and infestations	Medisorb Naltrexone 190mg--Combined	21	157
other	Nasopharyngitis	Infections and infestations	Placebo to 380mg	8	60
other	Nasopharyngitis	Infections and infestations	380mg to 380mg	8	115
other	Nasopharyngitis	Infections and infestations	Placebo to 190mg	6	55
other	Nasopharyngitis	Infections and infestations	190mg to 190mg	15	102
other	Upper respiratory tract infection NOS	Infections and infestations	Medisorb Naltrexone 380mg--Combined	18	175
other	Upper respiratory tract infection NOS	Infections and infestations	Medisorb Naltrexone 190mg--Combined	18	157
other	Upper respiratory tract infection NOS	Infections and infestations	Placebo to 380mg	6	60
other	Upper respiratory tract infection NOS	Infections and infestations	380mg to 380mg	12	115

1 to 10 of 264Source ClinicalTrials.gov

See all 264 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Medisorb Naltrexone 380mg--Combined
Total, all-cause mortality	Medisorb Naltrexone 190mg--Combined
Total, all-cause mortality	Placebo to 380mg
Total, all-cause mortality	380mg to 380mg
Total, all-cause mortality	Placebo to 190mg
Total, all-cause mortality	190mg to 190mg
Total, other adverse events	Medisorb Naltrexone 380mg--Combined	143	175
Total, other adverse events	Medisorb Naltrexone 190mg--Combined	130	157
Total, other adverse events	Placebo to 380mg	51	60
Total, other adverse events	380mg to 380mg	92	115

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Medisorb Naltrexone 380 mg vs Medisorb Naltrexone 190 mg: Number of Participants Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While in Study

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01218971

GET https://conductscience.org/api/trials/v1/NCT01218971/events?page=2

API reference For AI assistants