About the Study

Sleepiness during the day is a battle no one should have to fight alone. Research can give us more answers.

This study will assess how well a study medicine works for sleepiness during the day as a result of a head injury.

What does the study involve?

People who take part in the study will:

• Take the study medicine for 12 weeks
• Visit the study center 7 times, which includes 5 overnight stays in a sleep lab (some sleep labs are similar to hotel rooms)

Participants in the study are randomly assigned (like flipping a coin) to one of 4 groups:

Group 1 50 mg/day of the study medicine

Group 2 150 mg/day of the study medicine

Group 3 250 mg/day of the study medicine

Group 4 Placebo (sugar pill/no active medicine)*

*What is a placebo?

The placebo helps doctors know whether the study medicine works and to what extent. No one knows who will get the placebo, not even the doctors. This is done randomly, like flipping a coin. In this study, there is a greater chance (75%) that you will receive the medicine.

What are the risks?

Study staff will review some possible risks with you before you sign up since side effects can occur with all medicines. Some risks of any medicine may be serious or life-threatening. Write down all of your questions before you go to your first visit at the study center. It is important that you understand what the study requires.