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 |
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).
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.
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
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1601 Northwest 12th Avenue
Miami, Florida 33136
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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Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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1400 East Boulder Street
Colorado Springs, Colorado 80909
Colorado Springs, Colorado 80909
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New York University School of Medicine NYU School of Medicine has a proud history that...
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Omaha, Nebraska 68105
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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