About the Vibrance Studies

The Vibrance Studies are researching the safety and effectiveness of an investigational study drug taken orally once daily and how it may work in adults 18–70 years of age with narcolepsy type 1 (NT1) or narcolepsy type 2 (NT2) for excessive daytime sleepiness (EDS) symptoms. Individuals with NT1 may be eligible for the Vibrance-1 Study, and individuals with NT2 may be eligible for the Vibrance-2 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 or NT2
  • Have a body mass index (BMI) between 18 and 35 kg/m2
  • Not have symptoms of narcolepsy 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 Studies lasts up to approximately 21 weeks and 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 one of these studies. A two-week medication washout occurs during this period, meaning participants will stop taking their standard narcolepsy 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 and eight weeks for the Vibrance-2 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, and participants will undergo a sleep study (polysomnography) and a Maintenance of Wakefulness Test.

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.

Safety Follow-Up Period

After participants stop taking the assigned 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

About the Study Drug

Orexin is a chemical in the brain that helps regulate the sleep/wake cycle. The investigational study drug being researched in the Vibrance Studies is ALKS 2680, an orexin-2 receptor agonist that may improve symptoms of sleep disorder, such as EDS in adults with NT1 or NT2 and cataplexy in adults with NT1. 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.

See if you may qualify