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Lay Description

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).

Category

  • Emergency Medicine
  • Nervous System
IRB Number
20180680HU
NCT Number
NCT03095066
Open to Enrollment
Yes

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Arm Groups

Study Contact


Regulatory Point of Contact
Lauri Kelly
+1 (210) 882-7117
che@uthscsa.edu

Regulatory Point of Contact
Anna Hernandez
(210) 567-0780
hernandeza6@uthscsa.edu

Regulatory Point of Contact
Lauri Kelly
lauri.kelly@va.gov

Regulatory Point of Contact
Muhammad Baig
Muhammad.baig@va.gov

Local Recruitment Point of Contact
Anna Hernandez
(210) 567-0780
hernandeza6@uthscsa.edu

Principal Investigator
Muhammad Baig