Clinical Trial 63248

Austin, TX 78731


Summary:

If you suffer from excessive daytime sleepiness due to idiopathic hypersomnia, you may want to consider the Vibrance-3 Study.

Study Purpose: The Vibrance-3 Study is researching the safety and effectiveness of a once-daily oral investigational study drug and how it may work in adults 18–70 years of age for the potential treatment of excessive daytime sleepiness (EDS) symptoms in adults with idiopathic hypersomnia (IH). The study drug, ALKS 2680, is an orexin-2 receptor agonist, meaning that it is designed to promote wakefulness by activating orexin – a chemical in the brain that helps regulate the sleep/wake cycle.

All participants who qualify will receive the study drug or placebo (a tablet that looks like the study drug but contains no active medicine), as well as study-related procedures and study-related laboratory tests at no cost. Compensation for time and travel may also be available.

Eligibility Criteria:
Eligible participants must:

  • Be 18–70 years of age
  • Experience excessive daytime sleepiness
  • Have a primary diagnosis of IH
  • Have a body mass index (BMI) between 18 and 40 kg/m2
  • Not have symptoms of IH secondary to another medical condition
  • Not have untreated or uncontrolled sleep apnea

Other inclusion and exclusion criteria apply.


Available At:

More Information:
A website has been created to provide more information about the Vibrance-3 Study, including what to expect if you enroll. CLICK HERE for more information.

or

View a list of participating research sites.

 


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.