Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Neurobehavioral Disinhibition Including Aggression, Agitation, and Irritability in Patients With Traumatic Brain Injury



Status:Recruiting
Conditions:Neurology, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 75
Updated:3/9/2019
Start Date:May 30, 2017
End Date:June 2020
Contact:Amy Cobbley
Email:acobbley@avanir.com
Phone:(949) 643-6834

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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).

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).

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.

Inclusion Criteria:

- Participants with traumatic brain injury (TBI)

- Participants with neurobehavioral disinhibition symptoms that are present after trauma
or after recovery of consciousness

- Score of ≥4 on the modified Clinical Global Impression of Severity (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
We found this trial at
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Maitland, Florida 32751
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Amherst, New York 14226
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Atlanta, Georgia 30312
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2200 Kernan Drive
Baltimore, Maryland 21207
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Centerville, Ohio 45459
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Charlestown, Massachusetts 02129
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Cincinnati, Ohio 45220
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1400 East Boulder Street
Colorado Springs, Colorado 80909
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Creve Coeur, Missouri 63141
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Cromwell, Connecticut 06416
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3505 Gaston Avenue
Dallas, Texas 75246
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Dearborn, Michigan 48124
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8875 Northwest 23rd Street
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Durham, North Carolina 27713
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65 James Street
Edison, New Jersey 08820
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7115 Leesburg Pike
Falls Church, Virginia 22043
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Indianapolis, Indiana 46254
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Los Angeles, California 90073
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Loveland, Colorado 80538
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550 1st Ave
New York, New York 10016
(212) 263-7300
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2810 East Del Mar Boulevard
Pasadena, California 91107
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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255 East Bonita Avenue
Pomona, California 91767
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Pomona, California 91767
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107 Meridian Way
Richmond, Kentucky 40475
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7401 Beaufont Springs Drive
Richmond, Virginia 23225
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Richmond, Virginia 23298
(804) 828-0100
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Rochester, Minnesota 55905
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Sherwood, Arkansas 72120
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Tucson, Arizona 85724
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Tuscaloosa, Alabama 35404
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785 Mamaroneck Avenue
White Plains, New York 10605
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