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

Phase 2

Terminated

• Conditions: Disinhibition Syndrome
• Interventions: Drug: Placebo; Drug: AVP-786

• Registration Number: NCT02534038
• Lead Sponsor: Avanir Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-25
• Study First Posted: 2015-08-27
• Study Start: 2015-12
• Primary Completion: 2017-10-03
• Study Completion: 2017-10-03
• Disposition First Submitted: 2018-10-02
• Disposition First Submitted QC: 2018-10-02
• Disposition First Posted: 2018-10-04
• Status Verified: 2020-10
• Results First Submitted: 2020-10-01
• Results First Submitted QC: 2020-10-01
• Last Update Submitted: 2020-10-01
• Results First Posted: 2020-10-26
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo drug to be taken twice a day for 6 weeks
AVP-786	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI)	Baseline; Week 6, Week 8, and Week 14

Secondary Outcome Measures

Name	Time	Method
Change From Baseline for the Total NPI Score	Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the NPI Total Caregiver Distress	Baseline; Week 6, Week 8, and Week 14
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
Change From the First Assessment for the Patient Global Impression of Change (PGIC) Scale	Week 3, Week 6, Week 11, and Week 14
Change From Baseline for the Quality of Relationships (QoR) Scale	Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Quality of Life (QoL) Scale	Baseline; Week 6, Week 8, and Week 14
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
Change From Baseline for the FBI Disinhibition Domain Score	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	Week 3, Week 6, Week 11, and Week 14
Change From Baseline for the Interpersonal Reactivity Index (IRI)	Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Center for Neurologic Study-Lability Scale (CNS-LS)	Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Mini-Mental State Examination (MMSE)	Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Cornell Scale for Depression in Dementia (CSDD)	Baseline; Week 6, Week 8, and Week 14
Change From Baseline for the Stroop Color and Word Task	Baseline; Week 6, Week 8, and Week 14

Trial Locations

Locations (1)

Cleveland Clinic Lou Ruvo Center for Brain Health; 🇺🇸 Las Vegas, Nevada, United States