Trial · NCT02534038
Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
NCT02534038, Phase 2, Terminated, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2020-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition. Trials, record NCT02534038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02534038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
- NCT number
- NCT02534038
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Disinhibition Syndrome
- Interventions
- AVP-786, Placebo
- First posted
- 2015-08-27
- Last updated
- 2026-05-13
- Results first posted
- 2020-10-26
- Limitations and caveats
- The study was terminated due to lack of enrollment.
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI) | Baseline; Week 6, Week 8, and Week 14 | |
| Secondary | Change From Baseline for the Total NPI Score | Baseline; Week 6, Week 8, and Week 14 | |
| Secondary | Change From Baseline for the NPI Total Caregiver Distress | Baseline; Week 6, Week 8, and Week 14 | |
| Secondary | Change From Baseline for the NPI Disinhibition Domain Caregiver Distress | Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14 | |
| Secondary | Change From Baseline for the Frontal Behavioral Inventory (FBI) Total Score | Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14 | |
| Secondary | Change From Baseline for the FBI Disinhibition Domain Score | Baseline; Week 1, Week 3, Week 6, Week 9, Week 11, and Week 14 | |
| Secondary | Change From the First Assessment for the Modified Clinical Global Impression of Change (mCGIC) Scale | Week 3, Week 6, Week 11, and Week 14 | |
| Secondary | Change From the First Assessment for the Patient Global Impression of Change (PGIC) Scale | Week 3, Week 6, Week 11, and Week 14 | |
| Secondary | Change From Baseline for the Quality of Relationships (QoR) Scale | Baseline; Week 6, Week 8, and Week 14 | |
| Secondary | Change From Baseline for the Quality of Life (QoL) Scale | Baseline; Week 6, Week 8, and Week 14 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI) | Baseline; Week 6, Week 8, and Week 14 | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Change From Baseline for the Total NPI Score | Baseline; Week 6, Week 8, and Week 14 | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Change From Baseline for the NPI Total Caregiver Distress | Baseline; Week 6, Week 8, and Week 14 | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Change From Baseline for the NPI Disinhibition Domain Caregiver Distress | Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14 | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Change From Baseline for the Frontal Behavioral Inventory (FBI) Total Score | Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14 | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Change From Baseline for the FBI Disinhibition Domain Score | Baseline; Week 1, Week 3, Week 6, Week 9, Week 11, and Week 14 | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Change From the First Assessment for the Modified Clinical Global Impression of Change (mCGIC) Scale | Week 3, Week 6, Week 11, and Week 14 | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Change From the First Assessment for the Patient Global Impression of Change (PGIC) Scale | Week 3, Week 6, Week 11, and Week 14 | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Change From Baseline for the Quality of Relationships (QoR) Scale | Baseline; Week 6, Week 8, and Week 14 | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. | ||
| SECONDARY | Change From Baseline for the Quality of Life (QoL) Scale | Baseline; Week 6, Week 8, and Week 14 | No efficacy analyses were conducted due to the limited number of participants enrolled prior to study termination (N=1). In order to protect the privacy of participants, the results of enrolled participants cannot be reported. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (6 Weeks) | STARTED | AVP-786; Placebo | 1 | |
| Period 1 (6 Weeks) | STARTED | Placebo; AVP-786 | 0 | |
| Period 1 (6 Weeks) | COMPLETED | AVP-786; Placebo | 1 | |
| Period 1 (6 Weeks) | COMPLETED | Placebo; AVP-786 | 0 | |
| Period 1 (6 Weeks) | NOT COMPLETED | AVP-786; Placebo | 0 | |
| Period 1 (6 Weeks) | NOT COMPLETED | Placebo; AVP-786 | 0 | |
| Period 2 (6 Weeks) | STARTED | AVP-786; Placebo | 1 | |
| Period 2 (6 Weeks) | STARTED | Placebo; AVP-786 | 0 | |
| Period 2 (6 Weeks) | COMPLETED | AVP-786; Placebo | 1 | |
| Period 2 (6 Weeks) | COMPLETED | Placebo; AVP-786 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
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 | Blood bilirubin increased | Investigations | Placebo | 0 | 1 | |
| other | Blood bilirubin increased | Investigations | AVP-786 | 1 | 1 | |
| other | Blood creatine phosphokinase increased | Investigations | Placebo | 0 | 1 | |
| other | Blood creatine phosphokinase increased | Investigations | AVP-786 | 1 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 1 |
| Total, all-cause mortality | AVP-786 | 0 | 1 |
| Total, other adverse events | Placebo | 0 | 1 |
| Total, other adverse events | AVP-786 | 1 | 1 |
| Total, serious adverse events | Placebo | 0 | 1 |
| Total, serious adverse events | AVP-786 | 0 | 1 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| AVP-786 vs Placebo: deaths from any cause | Trial comparisons |
| AVP-786 vs Placebo: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Stroop Color-Word Test | Secondary outcome |
Source ConductCognition
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/NCT02534038
GET https://conductscience.org/api/trials/v1/NCT02534038/registered