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

NCT02534038 | Terminated Phase 2 Results

• 1 other identifier: 15-AVP-786-203
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder.

Conditions

Disinhibition Syndrome

Keywords

Disinhibition

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory (NPI)

  Baseline; Week 6, Week 8, and Week 14

Secondary Outcomes (14)

• 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 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo drug to be taken twice a day for 6 weeks

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.

Drug: AVP-786

Interventions

AVP-786 DRUG

d6-DM/Q

Also known as: Deuterated (d6)-dextromethorphan (DM)/Quinidine (Q)

AVP-786

Placebo DRUG

matching placebo

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Avanir Pharmaceuticals: lead

Study Sites (1)

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, 89106, United States

Location

Limitations and Caveats

The study was terminated due to lack of enrollment.

Results Point of Contact

• Title: Sanjay Dubé, M.D.
• Organization: Avanir Pharmaceuticals, Inc.

sdube@avanir.com

949-389-6700

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 27, 2015
• Study Start: December 1, 2015
• Primary Completion: October 3, 2017
• Study Completion: October 3, 2017
• Last Updated: October 26, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-10

Locations

US (1)