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)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Traumatic Brain Injury
    Traumatic Cerebral Oedema
  • Age: Between 18 - 70 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects must have TBI, an injury to the brain produced by external physical force, after a non-penetrating head trauma. Six months or more must elapse between the injury and screening.
    2. Subjects with TBI must meet the modified VA/DoD classification for complicated mild TBI, moderate TBI, or severe TBI
    3. Subjects with TBI's history must be confirmed by medical record or clinician report
    4. Subjects must have had no further head trauma in the 6 months prior to Screening
    5. Subjects should have a history of aggression, agitation, or irritability, which was not present before the injury, was presented after the injury or after recovery of consciousness, persisted past the acute post injury period and are not explained by a pre-existing diagnosis.
    6. Subjects would show behavioral disinhibition symptoms of aggression, agitation, or irritability at least weekly, be severe enough to interfere with daily routine, cause distress, and need to be treated with medication.
    7. Subjects would be between the ages of 18 and 75 years old
    8. Subjects and caregivers must have sufficient comprehension and cooperation to enable compliance with all procedures and assessments.
    9. Female of childbearing potential must have been practicing a medically-acceptable method of birth control for at least 1 month prior to randomization and continue with the same method until 30 days after the last dose or be surgically sterile or post-menopausal.
    10. Subjects must have a reliable caregiver who lives in close proximity or in the same household or interacts with the patient at least 2 hours per day for at least 3 days a week; is able and willing to comply with study procedures; attends all in-clinic study visits; and ensures that the patient ingests study drug as instructed.
    11. Subjects and caregivers must be willing to sign and receive a copy of the patient or caregiver informed consent form (ICF) after the nature and risks of study participation have been fully explained

You may not be eligible for this study if the following are true:

    1. Subjects with progressive dementia, any progressive neurological disorders, or progressive deterioration in function.
    2. Subjects who have had any penetrating head trauma.
    3. Subjects with pseudobulbar affect (PBA).
    4. Subjects with significant symptoms of a depressive disorder, or a score > 14 on the Patient Health Questionnaire-9 (PHQ-9) at the Screening
    5. Subjects with a history of neurodevelopmental, mood, or anxiety disorder
    6. Subjects with a history of or current clinical symptoms of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, or borderline personality disorder as defined in the DSM-5.
    7. Subjects with any seizures during the 6 months prior to Screening
    8. Subjects with myasthenia gravis (a contraindication for quinidine).
    9. Subjects with any personal history of complete heart block, QTc prolongation, or torsades de pointes
    10. Subjects with any family history of congenital QT interval prolongation syndrome.
    11. Subjects who currently are receiving DM/d6-DM co-administered with Q.
    12. Subjects with history of hypersensitivity to benzodiazepines (e.g., lorazepam).
    13. Subjects with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study
    14. Subjects with history of postural syncope or any history of unexplained syncope
    15. Subjects with a history of substance and/or alcohol or cannabis use disorder
    16. Subjects planning on initiating recreational or medicinal marijuana use during the study
    17. Females of childbearing potential with a positive pregnancy test at Screening or those who are breastfeeding or planning to become pregnant during the study
    18. Subjects who are currently participating in, or who have participated in other interventional (drug or device) clinical study within 30 days prior to randomization.
    19. Subjects residing in nursing homes



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