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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Avanir Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02534038
First received: August 11, 2015
Last updated: July 11, 2016
Last verified: July 2016
  Purpose
Treatment of disinhibition syndrome in participants with Neurodegenerative Disorder including frontotemporal dementia, Alzheimer's disease, progressive supranuclear palsy, corticobasal degeneration, dementia with Lewy bodies, vascular cognitive disorders, or Huntington's disease.

Condition Intervention Phase
Disinhibition Syndrome
Drug: AVP-786
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • Change from Baseline in the Disinhibition Domain of the Neuropsychiatric Inventory [ Time Frame: Baseline, week 1, week 3, week 9 and week 11 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline for the Total Neuropsychiatric Inventory (NPI) Score [ Time Frame: Baseline, week 6, week 8 and week 14 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Neuropsychiatric Inventory Total Caregiver Distress [ Time Frame: Baseline, week 6, week 8 and week 14 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Neuropsychiatric Inventory Disinhibition Domain Caregiver Distress [ Time Frame: Baseline, week 1, week 3, week 6, week 8, week 9 , week 11 and week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Frontal Behavioral Inventory (FBI) Disinhibition Domain Score [ Time Frame: Baseline, week 1, week 3, week 6, week 9 , week 11 and week 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Quality of Relationships (QoR) Scale [ Time Frame: Baseline, week 6, week 8 and week 14 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Quality of Life (QoL) Scale [ Time Frame: Baseline, week 6, week 8 and week 14 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Interpersonal Reactivity Index (IRI) [ Time Frame: Baseline, week 6, week 8 and week 14 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Center for Neurologic Study-Lability Scale (CNS-LS) [ Time Frame: Baseline, week 6, week 8 and week 14 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Mini-Mental State Examination (MMSE) [ Time Frame: Baseline, week 6, week 8 and week 14 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: Baseline, week 6, week 8 and week 14 ] [ Designated as safety issue: No ]
  • Change from Baseline for the Stroop Color and Word Task [ Time Frame: Baseline, week 6, week 8 and week 14 ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: December 2015
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo drug to be taken twice a day for 6 weeks
Drug: Placebo
matching placebo
Active Comparator: 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 two doses of AVP-786 twice a day at different time points for 5 weeks.
Drug: AVP-786
d6-DM/Q
Other Name: Deuterated (d6)-dextromethorphan (DM)/Quinidine (Q)

Detailed Description:

Eligible participants for this study must have a diagnosis of Neurodegenerative Disorder and must have behavior from the disinhibited behavior from the definition of the behavioral variant of frontotemporal dementia.

This is a multicenter, randomized, double-blind, placebo-controlled study consisting of 12 weeks of treatment.

Approximately 12 participants will be enrolled at approximately 2 centers in the United States.

Study medication will be administered orally twice-daily from Day 1 through Day 99. Screening must occur within 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02534038

Contacts
Contact: Fred Ledon 9493896724 FLedon@avanir.com
Contact: Paul Shin 9492685930 PShin@avanir.com

Locations
United States, Nevada
Recruiting
Las Vegas, Nevada, United States, 89106
Sponsors and Collaborators
Avanir Pharmaceuticals
  More Information

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02534038     History of Changes
Other Study ID Numbers: 15-AVP-786-203 
Study First Received: August 11, 2015
Last Updated: July 11, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Avanir Pharmaceuticals:
Disinhibition

Additional relevant MeSH terms:
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on January 18, 2017