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

Sponsor ID
17-AVP-786-205
Clinicaltrials.gov ID
NCT03095066
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
17-AVP-786-205
Trial Details
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Age
18 - 75 Years
Therapeutic Area
  • Neurobehavioral Disinhibition
    • Sex
    Female & Male
    Trial Dates
    May 2017 - Aug 2022
    Healthy Volunteers
    No
    • 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
    • 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 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).

    Additional Study Details

    Phase
    Phase 2
    Study Drug
    Drug: Placebo
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    168
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Participants with TBI
    • * Participants with neurobehavioral disinhibition symptoms that are present after trauma or after recovery of consciousness

    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
    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

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    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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