Disinhibition SyndromePhase 2NCT02534038
Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
A Phase 2 study testing AVP-786 in people with Disinhibition Syndrome, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
Trial summary
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Disinhibition Syndrome
- What is being tested?
- AVP-786
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2015to 3 Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented diagnosis of a Neurodegenerative Disorder including frontotemporal dementia, Alzheimer's disease (AD), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), dementia with Lewy bodies (DBL), vascular cognitive disorders, or Huntington's disease, at least 3 months prior to Baseline
- The participant has behavior from 2 of the 3 categories of disinhibited behavior from the definition of the behavioral variant of frontotemporal dementia
- The behavioral changes are not due to a pre-existing major psychiatric disorder (e.g., schizophrenia, bipolar disease, etc.) and are not due to the direct effect of systemic illness, drug action, or substance use
- Disinhibition scale score of ≥4 on the 3 core disinhibition items of the Frontal Behavioral Inventory (FBI) at Screening and Baseline
Who cannot join
- Participants with symptoms of disinhibition that is not secondary to Neurodegenerative Disorders
- Participants with myasthenia gravis
- Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma or untreated prostate cancer], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, 89106
About this study
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of AVP-786 for the Treatment of Disinhibition in Patients With Neurodegenerative Disorders
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
Read the detailed description
Eligible participants for this study must have a diagnosis of Neurodegenerative Disorder and must exhibit disinhibition syndrome of sufficient severity to warrant treatment.
This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study consisting of two 6-week treatment periods.
Approximately 12 participants will be enrolled at approximately 2 centers in the United States.
Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
- Conditions
- Disinhibition Syndrome
- Being tested
- AVP-786, Placebo
- Keywords
- Disinhibition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVP-786Drug
Also called Deuterated (d6)-dextromethorphan (DM)/Quinidine (Q)
d6-DM/Q
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo drug to be taken twice a day for 6 weeks Receives: Drug: Placebo |
| AVP-786 | Active comparator | Participants randomized to AVP-786 will take one dose of AVP-786 once a day and one dose of placebo once a day for the first 7 days; from day 8, participants will receive AVP-786 twice a day for 5 weeks. Receives: Drug: AVP-786 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI)
Measured: Baseline; Week 6, Week 8, and Week 14
Secondary outcomes (14)
Change From Baseline for the Total NPI Score
Measured: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the NPI Total Caregiver Distress
Measured: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the NPI Disinhibition Domain Caregiver Distress
Measured: Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14
Change From Baseline for the Frontal Behavioral Inventory (FBI) Total Score
Measured: Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14
Change From Baseline for the FBI Disinhibition Domain Score
Measured: Baseline; Week 1, Week 3, Week 6, Week 9, Week 11, and Week 14
Change From the First Assessment for the Modified Clinical Global Impression of Change (mCGIC) Scale
Measured: Week 3, Week 6, Week 11, and Week 14
Change From the First Assessment for the Patient Global Impression of Change (PGIC) Scale
Measured: Week 3, Week 6, Week 11, and Week 14
Change From Baseline for the Quality of Relationships (QoR) Scale
Measured: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Quality of Life (QoL) Scale
Measured: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Interpersonal Reactivity Index (IRI)
Measured: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Center for Neurologic Study-Lability Scale (CNS-LS)
Measured: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Mini-Mental State Examination (MMSE)
Measured: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Cornell Scale for Depression in Dementia (CSDD)
Measured: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Stroop Color and Word Task
Measured: Baseline; Week 6, Week 8, and Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study start1 Dec 2015
- Primary completion3 Oct 2017
- Study completion3 Oct 2017
Why it stopped: The study was terminated prematurely because of difficulty with recruiting.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Disinhibition SyndromeStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534038
- Sponsor's protocol ID
- 15-AVP-786-203
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2015
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of AVP-786 for the Treatment of Disinhibition in Patients With Neurodegenerative Disorders
- ClinicalTrials.gov ID
- NCT02534038
- Acronym / sponsor ID
- 15-AVP-786-203
- Conditions
- Disinhibition Syndrome
- Keywords
- Disinhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated prematurely because of difficulty with recruiting.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 3 Oct 2017 (actual)
- Study completion
- 3 Oct 2017 (actual)
- First posted
- 27 Aug 2015 (estimated)
- Results
- Posted 26 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.
Detailed description
Eligible participants for this study must have a diagnosis of Neurodegenerative Disorder and must exhibit disinhibition syndrome of sufficient severity to warrant treatment.
This is a multicenter, randomized, double-blind, placebo-controlled, cross-over study consisting of two 6-week treatment periods.
Approximately 12 participants will be enrolled at approximately 2 centers in the United States.
Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo drug to be taken twice a day for 6 weeks |
| AVP-786 | Active comparator | Drug: AVP-786Participants randomized to AVP-786 will take one dose of AVP-786 once a day and one dose of placebo once a day for the first 7 days; from day 8, participants will receive AVP-786 twice a day for 5 weeks. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Documented diagnosis of a Neurodegenerative Disorder including frontotemporal dementia, Alzheimer's disease (AD), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), dementia with Lewy bodies (DBL), vascular cognitive disorders, or Huntington's disease, at least 3 months prior to Baseline
- The participant has behavior from 2 of the 3 categories of disinhibited behavior from the definition of the behavioral variant of frontotemporal dementia
- The behavioral changes are not due to a pre-existing major psychiatric disorder (e.g., schizophrenia, bipolar disease, etc.) and are not due to the direct effect of systemic illness, drug action, or substance use
- Disinhibition scale score of ≥4 on the 3 core disinhibition items of the Frontal Behavioral Inventory (FBI) at Screening and Baseline
Key exclusion criteria (3 listed)
- Participants with symptoms of disinhibition that is not secondary to Neurodegenerative Disorders
- Participants with myasthenia gravis
- Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma or untreated prostate cancer], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVP-786Also: Deuterated (d6)-dextromethorphan (DM)/Quinidine (Q)d6-DM/Q | Drug | AVP-786 |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI)
Time frame: Baseline; Week 6, Week 8, and Week 14
14 secondary outcomes
Change From Baseline for the Total NPI Score
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the NPI Total Caregiver Distress
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the NPI Disinhibition Domain Caregiver Distress
Time frame: Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14
Change From Baseline for the Frontal Behavioral Inventory (FBI) Total Score
Time frame: Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14
Change From Baseline for the FBI Disinhibition Domain Score
Time frame: Baseline; Week 1, Week 3, Week 6, Week 9, Week 11, and Week 14
Change From the First Assessment for the Modified Clinical Global Impression of Change (mCGIC) Scale
Time frame: Week 3, Week 6, Week 11, and Week 14
Change From the First Assessment for the Patient Global Impression of Change (PGIC) Scale
Time frame: Week 3, Week 6, Week 11, and Week 14
Change From Baseline for the Quality of Relationships (QoR) Scale
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Quality of Life (QoL) Scale
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Interpersonal Reactivity Index (IRI)
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Center for Neurologic Study-Lability Scale (CNS-LS)
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Mini-Mental State Examination (MMSE)
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Cornell Scale for Depression in Dementia (CSDD)
Time frame: Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Stroop Color and Word Task
Time frame: Baseline; Week 6, Week 8, and Week 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Otsuka Clinical Trial WebsiteLink provided by the sponsor.
- Otsuka Clinical Trial TransparencyLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AVP-786 in people with Disinhibition Syndrome, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI) (time frame: Baseline; Week 6, Week 8, and Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.