Trial · NCT03594123
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
NCT03594123, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2023-11-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type. Trials, record NCT03594123. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03594123
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
- NCT number
- NCT03594123
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 259 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Alzheimer's Disease
- Interventions
- Brexpiprazole, Brexpiprazole
- First posted
- 2018-07-20
- Last updated
- 2023-11-14
- Results first posted
- 2023-11-14
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity | From first dose through 30 days after last dose of study drug (Up to approximately Week 16) | An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs with an onset date on or after the first dose of brexpiprazole. They are all adverse events that started after start of brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study therapy. Adverse events were graded on a 3-point scale. The intensity of an adverse experience was defined as follows: 1 = Mild: Discomfort noticed, but no disruption to daily activity, 2 = Moderate: Discomfort sufficient to reduce or affect normal daily activity, and 3 = Severe: Inability to work or perform normal daily activity. |
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 | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity | From first dose through 30 days after last dose of study drug (Up to approximately Week 16) | Safety Sample comprised of those participants who signed an informed consent form (ICF) for the trial and received at least one dose of brexpiprazole in Trial 331-201-00182. As prespecified in the SAP, data was analyzed based on the treatments (Brexpiprazole or Placebo) received in parent study 331-14-213. Participants received brexpiprazole 2 or 3 mg or placebo in the parent study, data for this study was analyzed and reported in a combined way for brexpiprazole 2 and 3 mg. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity | Prior Brexpiprazole | Mild | 20.9 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity | Prior Placebo | Mild | 13.5 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity | Prior Brexpiprazole | Moderate | 9.2 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity | Prior Placebo | Moderate | 19.8 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity | Prior Brexpiprazole | Severe | 3.1 | percentage of participants | |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity | Prior Placebo | Severe | 0 | percentage of participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prior Brexpiprazole | 163 | |
| Overall Study | STARTED | Prior Placebo | 96 | |
| Overall Study | Efficacy Sample: | Prior Brexpiprazole | 159 | |
| Overall Study | Efficacy Sample: | Prior Placebo | 95 | |
| Overall Study | COMPLETED | Prior Brexpiprazole | 142 | |
| Overall Study | COMPLETED | Prior Placebo | 87 | |
| Overall Study | NOT COMPLETED | Prior Brexpiprazole | 21 | |
| Overall Study | NOT COMPLETED | Prior Placebo | 9 |
Source ClinicalTrials.gov
Adverse events16
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 | Nasopharyngitis | Infections and infestations | Prior Brexpiprazole | 0 | 163 | |
| other | Nasopharyngitis | Infections and infestations | Prior Placebo | 5 | 96 | |
| serious | Blood Loss Anaemia | Blood and lymphatic system disorders | Prior Brexpiprazole | 1 | 163 | |
| serious | Blood Loss Anaemia | Blood and lymphatic system disorders | Prior Placebo | 0 | 96 | |
| serious | Haemorrhoids | Gastrointestinal disorders | Prior Brexpiprazole | 1 | 163 | |
| serious | Haemorrhoids | Gastrointestinal disorders | Prior Placebo | 0 | 96 | |
| serious | Fall | Injury, poisoning and procedural complications | Prior Brexpiprazole | 3 | 163 | |
| serious | Fall | Injury, poisoning and procedural complications | Prior Placebo | 0 | 96 | |
| serious | Femur Fracture | Injury, poisoning and procedural complications | Prior Brexpiprazole | 1 | 163 | |
| serious | Femur Fracture | Injury, poisoning and procedural complications | Prior Placebo | 0 | 96 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prior Brexpiprazole | 0 | 163 |
| Total, all-cause mortality | Prior Placebo | 0 | 96 |
| Total, other adverse events | Prior Brexpiprazole | 0 | 163 |
| Total, other adverse events | Prior Placebo | 5 | 96 |
| Total, serious adverse events | Prior Brexpiprazole | 6 | 163 |
| Total, serious adverse events | Prior Placebo | 0 | 96 |
Source ClinicalTrials.gov
Papers5
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prior Brexpiprazole vs Prior Placebo: deaths from any cause | Trial comparisons |
| Prior Brexpiprazole vs Prior Placebo: 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/NCT03594123
GET https://conductscience.org/api/trials/v1/NCT03594123/registered