About the Brilliance Studies

The Brilliance Studies are researching an investigational study drug taken orally (by mouth) and how it may work in adults with narcolepsy type 1 (NT1). An investigational drug is one that has not been approved by any regulatory agency (for example, the US Food and Drug Administration [FDA]) to treat any disease. The Brilliance Studies are researching the safety and effectiveness of an investigational study drug taken orally in adults 18–70 years of age and will also evaluate whether the study drug may help improve symptoms of excessive daytime sleepiness (EDS) and cataplexy.

Who Can Participate?

To participate in the Brilliance Studies, you must:

  • Be 18–70 years of age
  • Experience EDS and cataplexy that impacts your ability to do everyday tasks
  • Have a confirmed diagnosis of NT1
  • Not have symptoms of narcolepsy because of another medical condition
  • Not have untreated or uncontrolled sleep apnea

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

Study Participation

Participation in the Brilliance Studies will last about 22 weeks. Throughout participation, individuals will be closely monitored and will visit the research site regularly for assessments, procedures, and health checks.

The studies are made up of the following three periods:

Screening (up to 8 weeks)

Participants will be evaluated to see if they are eligible to join these studies. A medication washout of at least two weeks occurs during this period, meaning participants will slowly 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, called a polysomnography (PSG), and a Maintenance of Wakefulness Test (MWT).

Treatment (up to 12 weeks)

Participants will be randomized to one of three treatment groups: two different amounts (doses) of the investigational drug, ALKS 2680, or a placebo, taken by mouth. During this period, two mandatory in-clinic overnight stays are required. Participants will also complete PSGs and MWTs to monitor the effects of the study drug.

Follow-Up (2 weeks)

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 will 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
  • Daily sleep, cataplexy, and study drug dosing diaries
  • Wearing a device to monitor sleep and wake patterns

See if you may qualify

About the Study Drug

Orexin is a chemical in the brain that helps regulate the sleep-wake cycle. This investigational 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, and in these studies, it is being compared to a placebo, which looks like the study drug but contains no active medicine. An investigational drug is one that has not been approved by any regulatory agency (for example, the US Food and Drug Administration [FDA]) to treat any disease.