There may be hope for your patients with neurobehavioral disinhibition including aggression, agitation, and irritability resulting from a traumatic brain injury (TBI).
If you are a physician and want to learn more about this TBI Clinical Research Study, please complete the form.
Brain Injury (TBI)
Advances in medical understanding of the lasting impact of a traumatic brain injury (TBI) continue to come to light as scientists and medical researchers uncover new information about how the human brain heals. There are currently no FDA-approved medications specifically for behavioral symptoms resulting from a TBI.
About a New Research Study Enrolling Patients
Avanir Pharmaceuticals, Inc. has launched a Phase 2 clinical research study designed to assess the efficacy, safety and tolerability of an investigational drug, AVP-786, for the potential treatment of neurobehavioral disinhibition including aggression, agitation, and irritability associated with a traumatic brain injury (TBI). AVP-786 is an oral capsule, which contains the active ingredients deudextromethorphan hydrobromide and quinidine sulfate. For the purposes of this research study, it is administered twice daily by the participant or their reliable study partner. Participation is expected to last a total of 17 weeks.
All study-related visits, tests, and study drugs will be provided at no-cost to the participant. In addition, compensation for completed study visits may be provided to them. You, of course, will continue to be their physician for non-study related medical needs.
Who is Eligible?
To pre-qualify, potential participants must:
- Be 18 to 75 years of age.
- Meet diagnostic criteria for a TBI as defined per protocol (mild, moderate, and severe).
- Have no additional head trauma in the past 6 months.
- Have a history of aggression, agitation, or irritability that was not present before the TBI.
- Have a reliable study partner.
- Be stable with use of other therapies for 3 months:
- Nondrug therapies (e.g. acupuncture, PT, etc.).
- Hypnotics at bedtime for insomnia.
- Antipsychotic or depression medications.
- Herbal supplements.