Doctors in this study want to evaluate the safety and effectiveness of an oral investigational drug for certain behavioral problems due to TBI.
People who are eligible and agree to participate in this study will be randomly assigned (like the flip of a coin) to receive the investigational drug or placebo. Placebo will look exactly like the investigational drug but contain no active medication. Participants have a 50% chance of being assigned to receive either study drug (investigational or placebo).
Participants, caregivers, the study doctor, and the study staff will not know the study drug assignments. However, in the event of an emergency, this information can be provided.
Participants in this study will take their assigned study drug once in the morning and once in the evening for approximately 12 weeks. Total study participation will last about 16 weeks, which includes six visits to the study center and two phone calls from the study staff.
Participants who are currently taking medication to treat TBI may be allowed to take it throughout this study. Additionally, if allowed by the study doctor, participants could receive oral lorazepam as rescue medication.