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Clinical Trials in the USA / NCT06843590
Recruiting Phase 2

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

NCT06843590 · tracked via the Priya Life Science USA tracker
Sponsor
Alkermes, Inc.
Phase
Phase 2
Started
2025-05-22
Last updated
2026-06-24

Condition(s) studied

Idiopathic Hypersomnia

Investigational drug(s) / intervention(s)

ALKS 2680 →Placebo

ALKS 2680: Oral tablet containing ALKS 2680 for daily, oral administration

Placebo: Oral placebo tablet for daily administration

Study summary

The purpose of this study is to measure the safety and decrease in daytime sleepiness in subjects with Idiopathic Hypersomnia when taking ALKS 2680 tablets compared with placebo tablets

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Alkermes Investigator Site Cullman Alabama Recruiting
Alkermes Investigator Site Phoenix Arizona Recruiting
Alkermes Investigator Site Little Rock Arkansas Recruiting
Alkermes Investigator Site Los Angeles California Recruiting
Alkermes Investigator Site Redwood City California Recruiting
Alkermes Investigator Site San Francisco California Recruiting
Alkermes Investigational Site Boulder Colorado Recruiting
Alkermes Investigator Site Colorado Springs Colorado Recruiting
Alkermes Investigator Site Brandon Florida Recruiting
Alkermes Investigator Site Miami Florida Recruiting
Alkermes Investigator Site Winter Park Florida Recruiting
Alkermes Investigator Site Atlanta Georgia Recruiting
Alkermes Investigator Site Macon Georgia Recruiting
Alkermes Investigator Site Stockbridge Georgia Recruiting
Alkermes Investigator Site Peoria Illinois Recruiting
Alkermes Investigator Site Kansas City Kansas Recruiting
Alkermes Investigational Site Boston Massachusetts Recruiting
Alkermes Investigator Site Lansing Michigan Recruiting
Alkermes Investigator Site Lincoln Nebraska Recruiting
Alkermes Investigator Site Middletown New Jersey Recruiting
Alkermes Investigator Site Denver North Carolina Recruiting
Alkermes Investigator Site Huntersville North Carolina Recruiting
Alkermes Investigator Site Canton Ohio Recruiting
Alkermes Investigator Site Cincinnati Ohio Recruiting
Alkermes Investigator Site Cleveland Ohio Recruiting
Alkermes Investigator Site Danville Pennsylvania Recruiting
Alkermes Investigator Site Philadelphia Pennsylvania Recruiting
Alkermes Investigator Site Wyomissing Pennsylvania Recruiting
Alkermes Investigator Site Columbia South Carolina Recruiting
Alkermes Investigator Site Austin Texas Recruiting
Alkermes Investigator Site San Antonio Texas Recruiting
Alkermes Investigator Site Sugar Land Texas Recruiting
Alkermes Investigator Site Sugarland Texas Recruiting
Alkermes Investigator Site Madison Wisconsin Recruiting
Alkermes Investigator Site Sydney New South Wales Recruiting
Alkermes Investigator Site Bedford Park South Australia Recruiting
Alkermes Investigator Site Clayton Victoria Recruiting
Alkermes Investigator Site Alken Belgium Recruiting
Alkermes Investigator Site Namur Belgium Recruiting
Alkermes Investigator Site Prague Czechia Recruiting

+ 10 more sites — see the full list on the official registry below.

More Alkermes, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06843590 on ClinicalTrials.gov ↗ ← All trials in the USA