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)
Brief description of study
Symptoms associated with TBI such as physical and verbal aggression, agitation and irritability are problematic, can be difficult to manage, can be disruptive, and can impact your/your family’s quality of life. Currently, there are no medications approved by the United States Food and Drug Administration (FDA) to treat aggression, agitation, and irritability in patients with TBI. The purpose of this research study is to test the safety and effectiveness of the investigational study drug, AVP-786, for the treatment of aggression, agitation, and irritability in subjects with complicated mild, moderate or severe TBI. An investigational drug is one that is not approved by the United States Food and Drug Administration (FDA). The study will also include a placebo for comparison. A placebo is a study drug look-alike, but contains no active ingredient. Placebo-controlled trials are commonly used and are designed to minimize assessment bias in research studies. AVP-786 is a combination of two medications; one medication is deudextromethorphan (d6-DM) and the other is quinidine (Q), which is given in a very low dose
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