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Sleep Medicine and Research Center: Current Studies

Information About a Research Study for Patients with Idiopathic Hypersomnia

WHAT IS THE PURPOSE OF THE STUDY?
The purpose of the study is to evaluate the safety and effectiveness of a study drug, called pitolisant, when compared with placebo in treating symptoms of idiopathic hypersomnia in adults.

WHO IS ELIGIBLE FOR THE STUDY?
You may be eligible if you:
  • Are 18 years of age or older
  • Have been diagnosed with idiopathic hypersomnia
  • Experience excessive daytime sleepiness
WILL I HAVE TO STOP MY CURRENT MEDICATIONS?
Some medications cannot be taken during the study. Medications that you take regularly should remain stable during the study. Other eligibility requirements will be reviewed by the study staff.

WHAT HAPPENS DURING THE STUDY?
Participation in this study is divided into 3 parts and will last 12-16 weeks.
  • The first part is the screening phase to determine if you are eligible to participate in the study. This phase consists of 2 office visits over 2-4 weeks.
  • Part two is the open-label phase during which you will receive pitolisant at a dose appropriate for you. This phase involves 2 office visits and 6 phone calls over 8 weeks.
  • If you are eligible to continue in the double-blind phase, you will receive either pitolisant at the same dose you were taking at the end of the open-label phase, or a placebo. Neither you nor the study staff will know which group you are in. This phase lasts 4 weeks and involves 1 office visit and 1 phone call.
There are 7 phone calls, during which the staff will ask how you are feeling and make sure you are taking your study drug.


There are 5 daytime office visits which can include the following procedures:
  • Collect information about you, your health, and your medications
  • Blood and urine collection (test for infections, medical issues, and drug use)
  • Pregnancy Test (if applicable)
  • Physical examination
  • Vital signs
  • Electrocardiogram (ECG)
  • Completion of questionnaires on an electronic handheld device that is provided to you
  • Computerized Cognitive Tests
  • Completion of a sleep diary and study drug dosing diary on an electronic handheld device that is provided to you

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.
You will be paid up to a total of $620 if you complete the study ($75 for each office visit and $35 for each phone call). You will only be paid for visits that you complete.

HOW DO I GET MORE INFORMATION?
Contact InessaLokshina at 314-205-6011 or Inessa.Lokshina@stlukes-stl.com.
or
Contact us at slhsleepresearch@stlukes-stl.com to schedule a phone call.