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About the study

The VIBRANCE-1 Study is researching an investigational study drug taken orally for the potential treatment of excessive daytime sleepiness (EDS) symptoms in adults diagnosed with narcolepsy type 1 (NT1). Individuals with NT1 may be eligible for the VIBRANCE-1 Study. Orexin is a chemical in the brain that helps regulate the sleep/wake cycle. The investigational study drug, ALKS 2680, is an orexin-2 receptor agonist that may improve symptoms of sleep disorders, such as EDS and cataplexy, in patients with NT1.

Involves approximately 21 visits, including 2-4 overnight visits & 12 which can be done by telephone. Participants will also be completing electronic diaries & questionnaires while at home. 

At clinic study visits, the study team will perform tests and procedures, including:
* Vital sign measurements
* Blood & urine sample collections for lab tests
* Electrocardiograms (ECGs)
* Physical exams
* Body weight measurements
* Questionnaires about quality of life & narcolepsy symptoms

Eligibility Requirements

Aged 18–70 years;
Experience excessive daytime sleepiness;
Primary diagnosis of NT1;
Body mass index (BMI) between 18 and 40 kg/m2;
Not have symptoms of narcolepsy secondary to another medical condition;
Not have untreated or uncontrolled sleep apnoea

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What's Involved

Participation in the VIBRANCE-1 Study consists of the following:
* SCREENING PERIOD (up to 6 weeks): 
To see if you are eligible to join this study. 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 (6 weeks): 
Participants will be randomized to receive one of three doses of the study drug or a placebo (a tablet that looks like the study drug but contains no active medicine) to be taken once daily. One mandatory in-clinic overnight stay is required during this period. The sleep study and Maintenance of Wakefulness Test will be repeated throughout the treatment period.
* OPEN LABEL EXTENSION PERIOD (7 weeks): 
This optional period will allow participants to receive the active study drug, even if they were initially assigned the placebo.
* SAFETY FOLLOW-UP PERIOD (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.

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