Clinical trial NCT02534038: Safety, Tolerability and Efficacy of AVP-786 for the Treatment of Disinhibition
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Disinhibition Syndrome
Keywords: Disinhibition
Lead sponsor: Avanir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-08-27
Enrollment: 1
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI)
timeFrame: Baseline; Week 6, Week 8, and Week 14
Secondary outcomes:
measure: Change From Baseline for the Total NPI Score
timeFrame: Baseline; Week 6, Week 8, and Week 14
measure: Change From Baseline for the NPI Total Caregiver Distress
timeFrame: Baseline; Week 6, Week 8, and Week 14
measure: Change From Baseline for the NPI Disinhibition Domain Caregiver Distress
timeFrame: Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14
measure: Change From Baseline for the Frontal Behavioral Inventory (FBI) Total Score
timeFrame: Baseline; Week 1, Week 3, Week 6, Week 8, Week 9, Week 11, and Week 14
measure: Change From Baseline for the FBI Disinhibition Domain Score
timeFrame: Baseline; Week 1, Week 3, Week 6, Week 9, Week 11, and Week 14
measure: Change From the First Assessment for the Modified Clinical Global Impression of Change (mCGIC) Scale
timeFrame: Week 3, Week 6, Week 11, and Week 14
measure: Change From the First Assessment for the Patient Global Impression of Change (PGIC) Scale
timeFrame: Week 3, Week 6, Week 11, and Week 14
measure: Change From Baseline for the Quality of Relationships (QoR) Scale
timeFrame: Baseline; Week 6, Week 8, and Week 14
measure: Change From Baseline for the Quality of Life (QoL) Scale
timeFrame: Baseline; Week 6, Week 8, and Week 14
measure: Change From Baseline for the Interpersonal Reactivity Index (IRI)
timeFrame: Baseline; Week 6, Week 8, and Week 14
measure: Change From Baseline for the Center for Neurologic Study-Lability Scale (CNS-LS)
timeFrame: Baseline; Week 6, Week 8, and Week 14
measure: Change From Baseline for the Mini-Mental State Examination (MMSE)
timeFrame: Baseline; Week 6, Week 8, and Week 14
measure: Change From Baseline for the Cornell Scale for Depression in Dementia (CSDD)
timeFrame: Baseline; Week 6, Week 8, and Week 14
measure: Change From Baseline for the Stroop Color and Word Task
timeFrame: Baseline; Week 6, Week 8, and Week 14
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
Study officials:
References: