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A Study of ALKS 2680 for Idiopathic Hypersomnia

This study is testing a new oral tablet called ALKS 2680 to see how safe it is and how well it reduces daytime sleepiness in people with Idiopathic Hypersomnia (a condition causing extreme daytime sleepiness). You would be given either ALKS 2680 or a placebo (an inactive pill that looks like the study drug) to take daily. Researchers will measure changes in your daytime sleepiness using a scale called the Epworth Sleepiness Scale (ESS) over 8 weeks. To join, you need to be between 18 and 70 years old. The study is currently unclear on its recruitment status, but plans to enroll about 126 people.

Study design
This interventional study is designed to compare ALKS 2680 to a placebo in about 126 participants. The phase of the study is not specified.
What's involved
You would take an oral tablet daily and follow specific lifestyle and contraception guidance. You would also need to adhere to actigraphy (a way to measure activity and sleep) and diary requirements.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes up to 8 weeks after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06843590

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Alkermes, Inc.
~126 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:ALKS 2680Placebo

At a glance

Recruiting sites
50 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level
Measured over Up to 8 weeks

Conditions

Idiopathic Hypersomnia

Explore related trials

Idiopathic Hypersomnia

Where it's being run

50 sites across 30 states
Texas4
California3
Florida3
Georgia3
Ohio3
Pennsylvania3
Italy3
Spain3

Study leadership

  • Medical Director · STUDY_DIRECTOR · Alkermes, Inc.

Who to contact

Director, Global Clinical Services
[email protected]
888-235-8008 (US Only)
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose levelUp to 8 weeks