This study is evaluating a potential treatment for behavioral changes resulting from a TBI.
The purpose of this study is to evaluate the safety and effectiveness of an investigational drug given to people with behavioral changes such as, agitation, aggression, and/or irritability after a TBI.
The results of this study will provide information about whether the investigational drug could one day help people who are experiencing TBI-related aggression, agitation, and irritability.
What will happen during this study?
Participants will be randomly assigned to receive the investigational drug, which is a drug that has not been approved as a treatment by any health authority, or a placebo. A placebo is a pill that looks just like the investigational drug but has no active ingredients. The term “study drug” refers to either the investigational drug or placebo.
This is a “double-blind study,” which means that study participants and their study partners, as well as the study doctor and study staff will not know who is being given which study drug (the investigational drug or placebo). This information can be provided in the event of an emergency.
Study Drug Routine:
Total participation time in the study will be approximately 17 weeks