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Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition

NCT ID: NCT02534038

Last Updated: 2020-10-26

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-10-03

Brief Summary

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Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.

Detailed Description

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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

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Disinhibition Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo drug to be taken twice a day for 6 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo

AVP-786

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.

Group Type ACTIVE_COMPARATOR

AVP-786

Intervention Type DRUG

d6-DM/Q

Interventions

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AVP-786

d6-DM/Q

Intervention Type DRUG

Placebo

matching placebo

Intervention Type DRUG

Other Intervention Names

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Deuterated (d6)-dextromethorphan (DM)/Quinidine (Q)

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avanir Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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15-AVP-786-203

Identifier Type: -

Identifier Source: org_study_id