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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).

Study category: Other

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Description

Structure: This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study. Duration: Patients will be enrolled in the study for up to 16 weeks, with up to a 4-week screening period and a 12-week treatment period. Study Treatment: The investigational product is AVP-786 (deudextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]), which is titrated over a 2-week period to d6-DM 42.63 mg/Q 4.9 mg (AVP-786-42.63/4.9) twice daily (BID). Control: Placebo capsules appearing identical to study medication will be used as control. Randomization: Eligible patients will be randomized into the study to receive AVP-786 or placebo. Dose Regimen:

Details
Age

Adult

Eligibility

Patients with TBI that is complicated-mild,1 moderate,2 or severe2 in intensity, as determined by the modified Veterans Administration/Department of Defense (VA/DoD) criteria. The neurobehavioral disinhibition symptoms must present after the trauma or after recovery of consciousness, must persist past the acute post-injury period, and cannot be accounted for by a preexisting neurobehavioral disorder diagnosis, substance use disorder, or other medical disorder.

Detailed Eligibility: Each eligible patient 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 3 days a week and is able and willing to comply with study procedures; attends all study visits and ensures that the patient ingests study drug as instructed. Caregivers must sign an informed consent form (ICF) for this study.

Phase

II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.

Type of Study

Treatment

Location

Medical Center of the Rockies

Principal Investigator
Julie Dunn

Julie Dunn

Study ID

Protocol Number: 17-6198

ClinicalTrials.gov: NCT03095066

Categories

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