About the Vibrance Studies

The Vibrance Studies are researching the safety and effectiveness of an investigational study drug taken orally once daily in adults 18–70 years of age with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH) for excessive daytime sleepiness (EDS) symptoms. Individuals with NT1 may be eligible for the Vibrance-1 Study, individuals with NT2 may be eligible for the Vibrance-2 Study, and individuals with IH may be eligible for the Vibrance-3 Study.

Who May Qualify

Eligible participants must meet the following criteria:

  • 18–70 years of age
  • Experience excessive daytime sleepiness
  • Have a primary diagnosis of NT1, NT2, or IH
  • Have a body mass index (BMI) between 18 and 40 kg/m2
  • Not have symptoms of narcolepsy or 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.

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Study Participation

Participation in the Vibrance-1 Study and the Vibrance-2 Study lasts up to approximately 21 weeks, and the Vibrance-3 Study lasts up to approximately 16 weeks. The Vibrance Studies consist of the following:

Screening Period

In all the Vibrance Studies, this period lasts up to six weeks. Participants will be evaluated to see if they are eligible to join one of these studies. A two-week medication washout occurs during this period, meaning participants will stop taking their standard narcolepsy or 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. During this period, participants will undergo a sleep study (polysomnography), and a Maintenance of Wakefulness Test.

Treatment Period

This period lasts six weeks for the Vibrance-1 Study, eight weeks for the Vibrance-2 Study, and eight weeks for the Vibrance-3 Study. Participants will be randomized 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.

Open-Label Extension Period

This optional period lasts seven weeks for the Vibrance-1 Study and five weeks for the Vibrance-2 Study and will allow all participants to receive the study drug, even if they were initially assigned the placebo. This period does not occur in the Vibrance-3 Study.

Safety Follow-Up Period

In all the Vibrance Studies, 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 narcolepsy symptoms

Participants who complete one of the Vibrance Studies 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 a previous Vibrance 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 these studies, it is being compared to a placebo, which looks like the study drug but contains no active medicine.

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