The Vibrance-1 Study Website Is Coming Soon

If you experience excessive daytime sleepiness (EDS) due to narcolepsy type 1, the Vibrance-1 Study may be an option.

Interested in taking part in this research?

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Seeking Participants for a New Study of Excessive Daytime Sleepiness

Adults 18–70 years of age with narcolepsy type 1 (NT1) are invited to see if they may qualify to take part in the Vibrance-1 Study.

Who Can Participate?

Eligible participants must:

  • Be 18–70 years of age
  • Experience excessive daytime sleepiness
  • Have a primary diagnosis of NT1
  • 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 criteria, which the study team will discuss with you during the prescreening process.

Study Design

Participation in the Vibrance-1 Study lasts up to approximately 21 weeks. Eligible participants will be chosen at random to receive the investigational study drug or a placebo to be taken orally once daily. A placebo looks just like the study drug but contains no active medicine.

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

The Vibrance-1 Study consists of the following:

Screening Period

This period lasts up to six weeks, and the purpose is to make sure the study is a good match for the potential participant. One mandatory in-clinic overnight stay is required. Participants will stop their standard narcolepsy medications for two weeks but will be closely monitored by the study team.

Treatment Period

This period lasts six weeks. Participants will receive one of three doses of the study drug or a placebo to be taken once daily. One mandatory in-clinic overnight stay is required.

Open-Label Extension Period

This optional seven-week period 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.

There will be approximately 21 visits to the study site during the Vibrance-1 Study. Of these, 12 will be performed via telephone call, seven will occur at the study site, and two visits require staying overnight at the study site. Along with vital sign measurements and blood sample collections, participants will undergo sleep studies (as a polysomnography) and Maintenance of Wakefulness Tests, among other assessments.