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Sleep Medicine and Research Center: Current Studies

Information About a Research Study for Patients with Narcolepsy

WHAT IS THE PURPOSE OF THE STUDY?
The purpose of the study is to evaluate an investigational drug as a possible treatment for narcolepsy. 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 has been approved by the St. Luke's Institutional Review Board and the United States FDA.

WHO CAN PARTICIPATE?
Individuals may be eligible to participate if they:
  • Are age 18 to 50
  • Have narcolepsy
  • Do not have sleep apnea
  • Are willing to complete an electronic sleep diary every day
WILL I HAVE TO STOP MY CURRENT MEDICATIONS?
Participants will have to stop any medication taken for narcolepsy (with a doctor's approval). There are some other medications that cannot be taken during the study.

WHAT HAPPENS DURING THE STUDY?
The study includes 1 daytime screening office visit, 3 sleep-lab visits that require staying overnight and the following day, and 1 daytime end of study office visit. Participation lasts approximately 4-7 weeks. Screening tests are done at the first 2 visits to ensure individuals are eligible to participate.

Participants will take one of two doses of active drug (SUVN-G3031) or placebo (an inactive substance) for 14 days. Participants have a 66% chance of receiving active drug and a 33% chance of receiving placebo.

Some of the procedures conducted during participation include:
  • Physical examination
  • Vital signs (blood pressure, body temperature, and heart rate)
  • Electrocardiogram (ECG)
  • Blood and urine specimen collection
  • Overnight testing to study your sleep patterns
  • Daytime testing to measure your alertness
  • Questionnaires
  • Review of medications and health changes

HOW MUCH TIME WILL THE STUDY TAKE?
Visit Type of Visit Approximate
Duration in Hours
Approximate Number of
Days to the Next Visit
Screen Visit Daytime office visit 2 7-28
Sleep Lab Visit 1 Overnight with next day testing 20 7
Sleep Lab Visit 2 Overnight with next day testing 20 7
Sleep Lab Visit 3 Overnight with next day testing 20 7
End of Study Visit Daytime office visit 2  


WILL IT COST ME ANYTHING TO PARTICIPATE IN THE STUDY?
  • There are no costs to take part in the study. Participants will be compensated $70 for each completed office visits and $250 for each of the completed sleep lab visits.
HOW DO I GET MORE INFORMATION?
Contact us at 314-205-6011 or kara.griffin@stlukes-stl.com.