About the study
The VIBRANCE-3 Study is researching an investigational study drug taken orally for the potential treatment of excessive daytime sleepiness (EDS) symptoms in adults diagnosed with idiopathic hypersomnia (IH). Individuals with IH may be eligible for the VIBRANCE-3 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, in patients with IH. Involves approximately 12 visits, including 2 overnight visits & 5 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 & IH symptoms.
What's involved
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 IH 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 (8 weeks):
Participants will be randomised 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.
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.
Participants who complete the Treatment Period may be eligible to roll over into a separate, 96-week Long-Term Extension study on ALKS 2680, at the last visit of the Treatment Period. These participants will not complete the Safety Follow-Up Period.
Visits required
Approximately 12 visits, including 2 overnight visits & 5 which can be done by telephone.
Eligibility criteria
- Aged 18–70 years
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Experience excessive daytime sleepiness
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Primary diagnosis of IH
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Body mass index (BMI) between 18 and 40 kg/m2
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Not have symptoms of IH secondary to another medical condition
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Not have poorly controlled or clinically significant sleep-disordered breathing
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Additional eligibility criteria apply
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If interested, complete the questionnaire at this link to see if you may be eligible: https://vibrancestudies.com/au.
Chief investigator: Dr Jian Eu Tai
Ethics approvals:
This clinical trial has been reviewed and approved by the Bellberry Human Research Ethics Committee (Application number: 2025-04-630) in accordance with the National Statement on Ethical Conduct in Human Research (2007 – incorporating all updates).
Find out more
Contact: Tony Zakharia / Francis Cheong
Call: (02) 9805 3293
Email: hypersomnolence@woolcock.org.au
