Clinical trial NCT03095066: Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Participants With Traumatic Brain Injury
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury (TBI).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neurobehavioral Disinhibition
Keywords: aggression
agitation
irritability
non-penetrating brain injury
traumatic brain injury
TBI
AVP-786
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-29
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, placebo-controlled study to evaluate AVP-786 for the treatment of neurobehavioral disinhibition including aggression, agitation, and irritability in participants with traumatic brain injury (TBI).

Detailed description: Eligible participants for this study must have a diagnosis of neurobehavioral disinhibition including aggression, agitation, and irritability that persists after brain injury.

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

Eligibility criteria: Inclusion Criteria:

* Participants with TBI
* Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness
* Score of ≥4 on the mCGI-S scale and the Agitation/Aggression or Irritability/Lability subscales of the Neuropsychiatric Inventory (NPI) scale at screening and baseline
* Participants with a reliable caregiver

Exclusion Criteria:

* Participants with significant symptoms of a major depressive disorder
* Participants with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder

Primary outcomes:
measure: Change from Baseline to Week 12 in the Composite of the Clinical Impression Severity Scores on the Neuropsychiatric Inventory Clinician Rating Scale (NPI-C) Subscales of Aggression, Agitation, and Irritability/Lability (NPI-C-3)
timeFrame: Baseline; Week 12
Secondary outcomes:
measure: Change from Baseline to Week 12 in Modified Clinical Global Impression of Change (mCGI-C) Raw Scores
timeFrame: Baseline; Week 12
measure: Change from Baseline to Week 12 in NPI-C Rating Scale Subscales Scores for Aggression, Agitation, Irritability/Lability, and Disinhibition
timeFrame: Baseline; Week 12
measure: Change from Baseline to Week 12 in Modified Clinical Global Impression of Severity (mCGI-S) Scale Scores
timeFrame: Baseline; Week 12
measure: Change from Baseline to Week 12 in Patient Global Impression of Severity (PGI-S) Scores
timeFrame: Baseline; Week 12
measure: Change from Baseline to Week 12 in Patient Global Impression of Change (PGI-C) Raw Scores
timeFrame: Baseline; Week 12
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa Veterans Affairs Medical Center
state: Alabama
city: Phoenix
country: United States
facility: Absolute Clinical Research Site#207
state: Arizona
city: Scottsdale
country: United States
facility: Perseverance Research Center Site#152
state: Arizona
city: Costa Mesa
country: United States
facility: ATP Clinical Research Site#150
state: California
city: La Jolla
country: United States
facility: Kaizen Brain Center #224
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research, LLC Site#216
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Site#157
state: California
city: Long Beach
country: United States
facility: Tibor Rubin VA Medical Center, SCIRE Biomedical Research Institute
state: California
city: Panorama City
country: United States
facility: Asclepes Research Centers - Panorama City Site #208
state: California
city: Pomona
country: United States
facility: The Neurology Group
state: California
city: Colorado Springs
country: United States
facility: Mountain Mind
state: Colorado
city: Denver
country: United States
facility: Mountain View Clinical Research, Inc. Site# 202
state: Colorado
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
city: Cromwell
country: United States
facility: Connecticut Clinical Research
state: Connecticut
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc
state: Florida
city: Coral Springs
country: United States
facility: Healthcare Innovative Institute, LLC Site# 173
state: Florida
city: Doral
country: United States
facility: Science Connections, LLC Site#161
state: Florida
city: Doral
country: United States
facility: Design Neuroscience Center, PL
state: Florida
city: Jupiter
country: United States
facility: Alphab Global Research Site#163
state: Florida
city: Maitland
country: United States
facility: Meridien Research
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute, Inc.
state: Florida
city: Miami
country: United States
facility: Project 4 Research
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute, Inc. Site#151
state: Florida
city: Okeechobee
country: United States
facility: Health Synergy Clinical Research
state: Florida
city: Sarasota
country: United States
facility: Roskamp Institute Clinic, Inc.
state: Florida
city: Tampa
country: United States
facility: USF Dept of Psychiatry and Behavioral Neurosciences Site# 214
state: Florida
city: Tampa
country: United States
facility: Meridien Research Site# 108
state: Florida
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience Site#184
state: Hawaii
city: Lexington
country: United States
facility: The University of Kentucky research foundation
state: Kentucky
city: Richmond
country: United States
facility: Baptist Health
state: Kentucky
city: Springfield
country: United States
facility: Sisu BHR Site#200
state: Massachusetts
city: Bloomfield Hills
country: United States
facility: Neurobehavioral Medicine Group #222
state: Michigan
city: Creve Coeur
country: United States
facility: Millennium Psychiatric Associates, LLC
state: Missouri
city: Ozark
country: United States
facility: Sharlin Health and Neurology
state: Missouri
city: Saint Louis
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Edison
country: United States
facility: JFK Johnson Rehabilitation Institute
state: New Jersey
city: Mount Arlington
country: United States
facility: The NeuroCognitive Insititute
state: New Jersey
city: New York
country: United States
facility: New York University School of Medicine Site #122
state: New York
city: Charlotte
country: United States
facility: Atrium Health - Carolinas Rehabilitation - Charlotte Site #166
state: North Carolina
city: Charlotte
country: United States
facility: New Hope Clinical Research Site#194
state: North Carolina
city: Durham
country: United States
facility: Carolina Headache Institute
state: North Carolina
city: Salisbury
country: United States
facility: Salisbury VAMC
state: North Carolina
city: Centerville
country: United States
facility: Valley Medical Research
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Middleburg Heights
country: United States
facility: North Star Medical Research, LLC Site#154
state: Ohio
city: Oklahoma City
country: United States
facility: IPS Research Site#196
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Columbia
country: United States
facility: WJB Dorn VA-Wm. Jennings Bryan Dorn VA Medical Center
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Site#140
state: Texas
city: San Antonio
country: United States
facility: Polytrauma Rehabilitation Center S. Texas VA Health Care System Site# 146
state: Texas
city: Draper
country: United States
facility: Cedar Clinical Research #221
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University #172
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Site#172
state: Virginia
city: Salem
country: United States
facility: Salem Research Institute Site# 138
state: Virginia
Study officials:
References: