About the Vibrance-3 Study

The Vibrance-3 Study is researching the safety and effectiveness of an investigational study drug taken orally once daily in adults 18–70 years of age with idiopathic hypersomnia (IH) for excessive daytime sleepiness (EDS) symptoms.

Who May Qualify

Eligible participants must meet the following criteria:

  • 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

There are additional eligibility requirements that the study team will explain to you.

See if you may qualify

Study Participation

Participation in the Vibrance-3 Study lasts up to approximately 16 weeks. The Vibrance-3 Study consists of the following:

Screening Period

This period lasts up to six weeks. Participants will be evaluated to see if they are eligible to join the study. A two-week medication washout occurs during this period, meaning participants will stop taking their standard IH medication for two weeks and will be closely monitored by the study team. One mandatory in-clinic overnight stay is required during this period. Participants will undergo a sleep study (polysomnography), and a Maintenance of Wakefulness Test.

Treatment Period

This period lasts eight weeks. Participants will be randomised to receive one of three doses of the study drug or a placebo to be taken once daily. During this period, one mandatory in-clinic overnight stay is required. Participants will undergo a sleep study (polysomnography) and up to two Maintenance of Wakefulness Tests.

Safety Follow-Up Period

After participants stop taking the study drug or placebo, the study team will check on the participants’ health during this two-week period.

Throughout this research, the study doctor may perform a number of tests and procedures, including but not limited to:

  • Vital sign measurements

  • Blood and urine sample collections for lab tests

  • Electrocardiograms (ECGs)

  • Physical exams

  • Body weight measurements

  • Questionnaires about quality of life and IH symptoms

Participants who complete the Vibrance-3 Study may be able to enroll in a long-term extension study, called the ALKS 2680-301 Study, where all participants will receive the study drug, even if they received the placebo in the Vibrance-3 Study.

About the Study Drug

This study drug is an orexin-2 receptor agonist, meaning that it is designed to target orexin – a chemical in the brain that helps regulate the sleep/wake cycle. ALKS 2680 is a tablet that is administered orally once daily, and in this study, it is being compared to a placebo, which looks like the study drug but contains no active medicine.

See if you may qualify