Has a
traumatic brain injury changed
who you are?

A traumatic brain injury (TBI) can change the way a person interacts with the world.
But the behavior changes are not their fault.

If you or someone you care for are experiencing aggression, agitation, or irritability, and these behaviors began after suffering a traumatic brain injury (TBI), consider participating in a research study that is evaluating an investigational drug for the potential treatment of behavioral changes resulting from a TBI.

To be eligible for this study, a potential participant must:

Additional criteria will be assessed by the study doctor.

All study‐related visits, tests, and study drugs will be provided at no-cost.
In addition, reimbursement for study‐related travel may be provided.

About Traumatic Brain Injury (TBI)

A TBI is a disruption of brain function resulting from an external physical force, including, but not limited to, one or more sports concussions, a bad fall or car crash, a close-by loud explosion or a non-penetrating skull injury.1 The brain’s healing response to the trauma may cause itself more damage through inflammation and scarring.2  Damage to the brain can cause behavioral changes by inhibiting the control of behaviors such as, aggression, agitation, and irritability.3

While behavioral changes resulting from a TBI can be common, there are currently no FDA-approved medications specifically for TBI-related aggression, agitation, and irritability. The purpose of this study is to explore whether an investigational drug may be safe and effective in managing TBI-related behavioral symptoms.


According to the National Center for Injury Prevention and Control, an estimated cumulative 5.3 million people are living with a TBI-related disability in the US.4

TBI Cases

It is understood that aggressive behavior occurs in 40-70% of TBI cases.5


Hospitalizations, ER visits, and tens of thousands of deaths annually have been linked to non-military cases of TBIs.6


Agitated behavior after a TBI can be persistent.7

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