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

Use our guide to learn which trials are right for you!

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
65 James Street
Edison, New Jersey 08820
?
mi
from
Edison, NJ
Click here to add this to my saved trials
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...
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
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...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Amherst, New York 14226
?
mi
from
Amherst, NY
Click here to add this to my saved trials
Atlanta, Georgia 30312
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
2200 Kernan Drive
Baltimore, Maryland 21207
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Centerville, Ohio 45459
?
mi
from
Centerville, OH
Click here to add this to my saved trials
Charlestown, Massachusetts 02129
?
mi
from
Charlestown, MA
Click here to add this to my saved trials
Cincinnati, Ohio 45220
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
1400 East Boulder Street
Colorado Springs, Colorado 80909
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Creve Coeur, Missouri 63141
?
mi
from
Creve Coeur, MO
Click here to add this to my saved trials
Cromwell, Connecticut 06416
?
mi
from
Cromwell, CT
Click here to add this to my saved trials
3505 Gaston Avenue
Dallas, Texas 75246
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Dearborn, Michigan 48124
?
mi
from
Dearborn, MI
Click here to add this to my saved trials
8875 Northwest 23rd Street
Doral, Florida 33172
?
mi
from
Doral, FL
Click here to add this to my saved trials
Durham, North Carolina 27713
?
mi
from
Durham, NC
Click here to add this to my saved trials
7115 Leesburg Pike
Falls Church, Virginia 22043
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Indianapolis, Indiana 46254
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90073
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Loveland, Colorado 80538
?
mi
from
Loveland, CO
Click here to add this to my saved trials
Maitland, Florida 32751
?
mi
from
Maitland, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
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...
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
2810 East Del Mar Boulevard
Pasadena, California 91107
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
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...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
255 East Bonita Avenue
Pomona, California 91767
?
mi
from
Pomona, CA
Click here to add this to my saved trials
2895 North Towne Avenue
Pomona, California 91767
?
mi
from
Pomona, CA
Click here to add this to my saved trials
107 Meridian Way
Richmond, Kentucky 40475
?
mi
from
Richmond, KY
Click here to add this to my saved trials
7401 Beaufont Springs Drive
Richmond, Virginia 23225
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
1040 North Mason Road
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Salem, Virginia 24153
?
mi
from
Salem, VA
Click here to add this to my saved trials
Salisbury, North Carolina 28144
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Sarasota, Florida 34243
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
2215 Wildwood Avenue
Sherwood, Arkansas 72120
?
mi
from
Sherwood, AR
Click here to add this to my saved trials
Shreveport, Louisiana 71105
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
541 Floyd Road
Spartanburg, South Carolina 29307
?
mi
from
Spartanburg, SC
Click here to add this to my saved trials
Tampa, Florida
?
mi
from
Tampa, FL
Click here to add this to my saved trials
1295 North Martin Avenue
Tucson, Arizona 85724
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
Tuscaloosa, Alabama 35404
?
mi
from
Tuscaloosa, AL
Click here to add this to my saved trials
785 Mamaroneck Avenue
White Plains, New York 10605
?
mi
from
White Plains, NY
Click here to add this to my saved trials