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
48
sites
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
Doral, Florida 33172
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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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Maitland, Florida 32751
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550 1st Ave
New York, New York 10016
(212) 263-7300
New York University School of Medicine NYU School of Medicine has a proud history that...
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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
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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255 East Bonita Avenue
Pomona, California 91767
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2895 North Towne Avenue
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
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Rochester, Minnesota 55905
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1040 North Mason Road
Saint Louis, Missouri 63141
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Salem, Virginia 24153
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Salisbury, North Carolina 28144
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Sarasota, Florida 34243
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2215 Wildwood Avenue
Sherwood, Arkansas 72120
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Shreveport, Louisiana 71105
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541 Floyd Road
Spartanburg, South Carolina 29307
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Tampa, Florida
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1295 North Martin Avenue
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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