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Sleep Medicine and Research Center: Current Studies

Research Study For Alternative to XYREM® or XYWAV™

WHAT IS THE PURPOSE OF THE STUDY?

The purpose of the study is to evaluate the long-term safety of an investigational drug in treating sleepiness and cataplexy in patients with narcolepsy.

The drug being evaluated is a new formulation of sodium oxybate. The current formulations of sodium oxybate (Xyrem®/Xywav™) must be taken twice each night, but the new formulation would be taken only once per night. Eligible participants will receive the investigational drug for up to two years at no cost. 

An investigational drug is one that is currently being tested and is not approved by the United States Food and Drug Administration (FDA). The research study is approved by the St. Luke’s Institutional Review Board and the United States FDA.

WHAT HAPPENS DURING THE STUDY?

Participation lasts up to 2 years and involves approximately 13 visits at the Sleep Medicine & Research Center, St. Luke's Hospital. 

Visits
  • Screening Office Visit (3 hours)
    • Collect information about demographics, health, and medications
    • Physical examination
    • Vital signs
    • Blood and urine collection (test for infections, medical issues, and drug use)
    • Electrocardiogram (ECG)
    • Questionnaires
    • Provide study instructions, restrictions and diary
  • Period 1
    • Weekly office visits for 2-5 weeks (1 hour)
      • Vital signs 
      • Adjust drug dose, if needed
  • Period 2
    • Office visit every 3 months (1 hour)
      • Vitals signs
      • Questionnaires
    • Pick up drug once per month
  • End of Study Office Visit (2 hours)
  • Follow-up Visit (15 minutes)
WHO IS ELIGIBLE FOR THE STUDY?

Patients may be eligible if they: 

  • are 16 years of age or older
  • have been diagnosed with narcolepsy 
  • are not using CPAP

Patients that take stimulant medications can continue them during the study. Some medications cannot be taken during the study. Other eligibility requirements will be reviewed by the study staff.

DOES IT COST ANYTHING TO PARTICIPATE IN THE STUDY?

There are no costs to take part in the study. Study drug is provided at no cost.

Compensation 
  • $50 per completed office visit
  • $25 to pick-up drug once per month
HOW DO I GET MORE INFORMATION?

Contact Kara at kara.griffin@stlukes-stl.com to schedule a phone call.