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Active, not 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 Spain tracker
Phase
Phase 2
Started
2025-05-22
Last updated
2026-09-25

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)

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

Trial sites (50)

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

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

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 Spain