Summary:
Study Summary:
If you suffer from excessive daytime sleepiness due to narcolepsy or idiopathic hypersomnia, you may want to consider the Vibrance Studies.
Study Purpose:
The Vibrance Studies are researching the safety and effectiveness of a once-daily oral investigational study drug and how it may work in adults 18–70 years of age for the potential treatment of excessive daytime sleepiness (EDS) symptoms in adults with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH). 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. The study drug, ALKS 2680, is an orexin-2 receptor agonist, meaning that it is designed to promote wakefulness by activating orexin – a chemical in the brain that helps regulate the sleep/wake cycle.
All participants who qualify will receive the study drug or placebo (a tablet that looks like the study drug but contains no active medicine), as well as study-related procedures and study-related laboratory tests at no cost. Compensation for time and travel may also be available.
Eligibility Criteria:
Eligible participants must:
- Be 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
Other inclusion and exclusion criteria apply.