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Evaluating ALKS 2680 for treating Idiopathic Hypersomnia

A Phase 2, Randomized, Parallel-Group, Double-Blind, Dose-Range-Finding Study to Evaluate the Safety and Efficacy of ALKS 2680 in Subjects With Idiopathic Hypersomnia (Vibrance-3)

Phase 2 Interventional Alkermes, Inc. · NCT06843590

This study is testing a new medication called ALKS 2680 to see if it can help people with Idiopathic Hypersomnia feel less sleepy during the day.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment96 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorAlkermes, Inc. Industry-sponsored
Locations48 sites (Cullman, Alabama and 47 other locations)
Trial IDNCT06843590 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and effectiveness of ALKS 2680, an orexin-2 receptor agonist, in reducing daytime sleepiness in individuals diagnosed with Idiopathic Hypersomnia. Participants will receive either ALKS 2680 or a placebo, and their responses will be monitored through various assessments. The study will adhere to strict eligibility criteria to ensure that participants have a confirmed diagnosis of Idiopathic Hypersomnia and do not have other sleep disorders that could affect the results.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with Idiopathic Hypersomnia who meet specific inclusion criteria and can comply with study protocols.

Not a fit: Patients with other comorbid sleep disorders or significant health issues that may interfere with the study are unlikely to benefit.

Why it matters

Potential benefit: If successful, this treatment could significantly improve daytime alertness and quality of life for patients with Idiopathic Hypersomnia.

How similar studies have performed: While this approach is novel in the context of Idiopathic Hypersomnia, similar studies targeting sleep disorders have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Is willing and able, in the opinion of the Investigator, to understand and comply with protocol requirements, including: lifestyle considerations and restrictions, adherence to contraception guidance, adherence to actigraphy and diary requirements, if receiving treatment for OSA, adherence to primary OSA therapy over the 30 days prior to Visit 1, and throughout the study, including during overnight visits.
* Meets the diagnostic criteria of Idiopathic Hypersomnia according to ICSD-3-TR guidelines, confirmed by the diagnostic evaluations (PSG/MSLT/actigraphy) within the previous 10 years

Exclusion Criteria:

* Has another comorbid sleep disorder or condition that may influence the sleep-wake cycle
* Has a history or presence at Visit 1 of other clinically significant (treated or untreated) illness, disease, abnormality, or surgical procedure that, in the opinion of the Investigator, might compromise subject safety, interfere with any study assessment, or affect the subject's ability to complete the study
* Is currently enrolled in another clinical study or used any investigational drug or device within 30 days prior to Visit 1
* Is currently pregnant, breastfeeding, or is planning to become pregnant during the study

Where this trial is running

Cullman, Alabama and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic HypersomniaIHsleepsleep disorderorexin-2 receptor agonistexcessive daytime sleepiness
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.