Summary:
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).
Qualified Participants Must:
Have experienced at least one traumatic brain injury at least 6 months ago
Have symptoms of aggression, agitation or irritability after injury
Be between 18 and 75 years of age
Have a caregiver able to attend all study visits
Not live in a nursing home
Qualified Participants May Receive:
Compensation is available for time and travel