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

Study Identifier:
17-AVP-786-205
ClinicalTrials.gov Identifier:
NCT03095066
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Results Availables

Study Protocol
Available Language: English
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Statistical Analysis Plan
Available Language: English
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Study Details

Medical Condition
  • Neurobehavioral Disinhibition
Study Drug
  • Drug: Placebo
  • Drug: AVP-786-28
  • Drug: AVP-786-42.63
Date
May 2017 - Aug 2022
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Participants with TBI
  • Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness
  • Score of ≥4 on the 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

Protocol Summary

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).

Study Locations

Location
Status
Location
Tuscaloosa Veterans Affairs Medical Center
Tuscaloosa, Alabama, United States, 35404
Status
N/A
Location
Absolute Clinical Research Site#207
Phoenix, Arizona, United States, 85051
Status
N/A
Location
Perseverance Research Center Site#152
Scottsdale, Arizona, United States, 85254
Status
N/A
Location
ATP Clinical Research Site#150
Costa Mesa, California, United States, 92626
Status
N/A
Location
Kaizen Brain Center #224
La Jolla, California, United States, 92037
Status
N/A
Location
Sunwise Clinical Research, LLC Site#216
Lafayette, California, United States, 94543
Status
N/A
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July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Participants with TBI
  • Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness
  • Score of ≥4 on the 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

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