Trial · NCT02694328
A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
NCT02694328, Phase 3, Completed, Alkermes, Inc.; results first posted 2020-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study). Trials, record NCT02694328. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02694328
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study)
- NCT number
- NCT02694328
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 561 participants, actual
- Lead sponsor
- Alkermes, Inc.
- Conditions
- Schizophrenia
- Interventions
- ALKS 3831, Olanzapine
- First posted
- 2016-02-29
- Last updated
- 2020-02-10
- Results first posted
- 2020-02-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Body Weight at Week 24 | Baseline and Week 24 | |
| Primary | Percentage of Participants With >/= 10% Weight Gain at Week 24 | Baseline and Week 24 | |
| Secondary | Percentage of Participants With >/= 7% Weight Gain at Week 24 | Baseline and Week 24 | |
| Secondary | Number of Participants Experiencing of Adverse Events (AEs) | 24 weeks |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Body Weight at Week 24 | Baseline and Week 24 | The full analysis set (FAS) population includes all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment | Percent change in body weight | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants With >/= 10% Weight Gain at Week 24 | Baseline and Week 24 | The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With >/= 7% Weight Gain at Week 24 | Baseline and Week 24 | The FAS population included all randomized subjects who received at least 1 dose of study drug and had at least 1 postbaseline weight assessment. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Experiencing of Adverse Events (AEs) | 24 weeks | The Safety Population includes all randomized subjects who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Body Weight at Week 24 | Olanzapine | 6.59 | Standard Error 0.668 | Percent change in body weight | |
| Percent Change From Baseline in Body Weight at Week 24 | ALKS 3831 | 4.21 | Standard Error 0.681 | Percent change in body weight | |
| Percentage of Participants With >/= 10% Weight Gain at Week 24 | Olanzapine | 29.8 | Percentage of participants | ||
| Percentage of Participants With >/= 10% Weight Gain at Week 24 | ALKS 3831 | 17.8 | Percentage of participants | ||
| Percentage of Participants With >/= 7% Weight Gain at Week 24 | Olanzapine | 42.7 | Percentage of participants | ||
| Percentage of Participants With >/= 7% Weight Gain at Week 24 | ALKS 3831 | 27.5 | Percentage of participants | ||
| Number of Participants Experiencing of Adverse Events (AEs) | Olanzapine | 227 | Participants | ||
| Number of Participants Experiencing of Adverse Events (AEs) | ALKS 3831 | 203 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Olanzapine | 276 | |
| Overall Study | STARTED | ALKS 3831 | 274 | |
| Overall Study | COMPLETED | Olanzapine | 176 | |
| Overall Study | COMPLETED | ALKS 3831 | 176 | |
| Overall Study | NOT COMPLETED | Olanzapine | 100 | |
| Overall Study | NOT COMPLETED | ALKS 3831 | 98 |
Source ClinicalTrials.gov
Adverse events46
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 | Dry mouth | Gastrointestinal disorders | Olanzapine | 22 | 276 | 22 |
| other | Dry mouth | Gastrointestinal disorders | ALKS 3831 | 35 | 274 | 36 |
| other | Extra dose administered | Injury, poisoning and procedural complications | Olanzapine | 17 | 276 | 29 |
| other | Extra dose administered | Injury, poisoning and procedural complications | ALKS 3831 | 14 | 274 | 18 |
| other | Weight increased | Investigations | Olanzapine | 100 | 276 | 102 |
| other | Weight increased | Investigations | ALKS 3831 | 68 | 274 | 68 |
| other | Waist circumference increased | Investigations | Olanzapine | 22 | 276 | 22 |
| other | Waist circumference increased | Investigations | ALKS 3831 | 17 | 274 | 17 |
| other | Blood creatine phosphokinase increased | Investigations | Olanzapine | 12 | 276 | 15 |
| other | Blood creatine phosphokinase increased | Investigations | ALKS 3831 | 14 | 274 | 16 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Olanzapine | 0 | 276 |
| Total, all-cause mortality | ALKS 3831 | 0 | 274 |
| Total, other adverse events | Olanzapine | 159 | 276 |
| Total, other adverse events | ALKS 3831 | 146 | 274 |
| Total, serious adverse events | Olanzapine | 7 | 276 |
| Total, serious adverse events | ALKS 3831 | 10 | 274 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Olanzapine vs ALKS 3831: Number of Participants Experiencing of Adverse Events (AEs) | Trial comparisons |
| Olanzapine vs ALKS 3831: deaths from any cause | Trial comparisons |
| Olanzapine vs ALKS 3831: serious adverse events | 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.
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/NCT02694328
GET https://conductscience.org/api/trials/v1/NCT02694328/events?page=2