Trial · NCT02141399
A Long-Term Safety Study of ALKS 5461
NCT02141399, Phase 3, Completed, Alkermes, Inc.; results first posted 2018-12-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Long-Term Safety Study of ALKS 5461. Trials, record NCT02141399. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02141399
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Long-Term Safety Study of ALKS 5461
- NCT number
- NCT02141399
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,485 participants, actual
- Lead sponsor
- Alkermes, Inc.
- Conditions
- Major Depressive Disorder
- Interventions
- ALKS 5461
- First posted
- 2014-05-19
- Last updated
- 2018-12-14
- Results first posted
- 2018-12-14
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | Up to 56 weeks |
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 | Incidence of Adverse Events (AEs) | Up to 56 weeks | The safety population included all subjects who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adverse Events (AEs) | ALKS 5461 | 1124 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ALKS 5461 | 1,485 | |
| Overall Study | COMPLETED | ALKS 5461 | 741 | |
| Overall Study | NOT COMPLETED | ALKS 5461 | 744 |
Source ClinicalTrials.gov
Adverse events66
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 | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | ALKS 5461 | 322 | 1,485 | 409 |
| other | Constipation | Gastrointestinal disorders | ALKS 5461 | 151 | 1,485 | 173 |
| other | Vomiting | Gastrointestinal disorders | ALKS 5461 | 116 | 1,485 | 134 |
| other | Dry mouth | Gastrointestinal disorders | ALKS 5461 | 87 | 1,485 | 95 |
| other | Headache | Nervous system disorders | ALKS 5461 | 156 | 1,485 | 198 |
| other | Dizziness | Nervous system disorders | ALKS 5461 | 150 | 1,485 | 179 |
| other | Somnolence | Nervous system disorders | ALKS 5461 | 124 | 1,485 | 142 |
| other | Upper respiratory tract infection | Infections and infestations | ALKS 5461 | 83 | 1,485 | 98 |
| other | Nasopharyngitis | Infections and infestations | ALKS 5461 | 80 | 1,485 | 88 |
| other | Insomnia | Psychiatric disorders | ALKS 5461 | 81 | 1,485 | 90 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ALKS 5461 | 2 | 1,485 |
| Total, other adverse events | ALKS 5461 | 1,124 | 1,485 |
| Total, serious adverse events | ALKS 5461 | 47 | 1,485 |
Source ClinicalTrials.gov
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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/NCT02141399
GET https://conductscience.org/api/trials/v1/NCT02141399/events?page=2