WHAT IS THE PURPOSE OF THE STUDY?
The purpose of the study is to assess the safety and efficacy of an investigational drug (FT218) in the treatment of idiopathic hypersomnia. FT218 (known commercially as LUMRYZ^®) is an oxybate drug approved by the FDA for the treatment of cataplexy or excessive daytime sleepiness in adults with narcolepsy.

WHO CAN PARTICIPATE?
Individuals may be eligible to participate if they:

• Are 18 to 75 years of age
• Have been diagnosed with idiopathic hypersomnia
• Do not have other disorders or conditions that could explain their daytime excessive sleepiness
• Are taking, or are willing to take, an oxybate drug
• Are willing to abstain from consuming alcohol and THC/cannabis
• Are willing to limit caffeine consumption

Patients already taking stimulant medications may continue them during the study. Some medications cannot be taken during the study. Other eligibility requirements will be reviewed by the study staff.

WHAT HAPPENS DURING THE STUDY?
Participation lasts about 42 weeks, including a screening period to determine eligibility. Eligible participants will take FT218 for approximately 38 weeks. During this period, there will be approximately 16 office visits and up to 5 telephone calls. There is a two-week period in which participants may receive FT218 or placebo to test for symptoms of withdrawal.

Some of the study procedures conducted during visits include the following:

• Review of medical history, current health, and prior and current medications
• Physical examinations
• Blood and urine tests
• Vital signs (blood pressure, pulse, body temperature, and respiratory rate)
• Height and weight
• ECG (electrocardiogram)
• Breath alcohol and urine drug testing
• Questionnaires about your symptoms and how they affect your daily functioning as well as how you are feeling

WILL IT COST ME ANYTHING TO PARTICIPATE IN THE STUDY?
There are no costs to take part in the study.
Participants are compensated $75-100 for each visit for up to $1800. Participants are only paid for completed visits.


HOW DO I GET MORE INFORMATION?
Complete the questions below and we will contact you for further information or call 314-205-6011.