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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520981-23-00

Acronym

ALKS 2680-203

Enrollment

Registered

2025-08-19

Start date

2025-08-26

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Hypersomnia (IH)

Brief summary

Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level.

Detailed description

Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level., • TEAEs • Clinical laboratory assessments • Vital signs • Safety ECG • C-SSRS

Interventions

DRUGALKS 2680

DRUGPlacebo to match ALKS 2680

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level.	—

Secondary

Measure	Time frame
Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level., • TEAEs • Clinical laboratory assessments • Vital signs • Safety ECG • C-SSRS	—

Countries

Belgium, Czechia, France, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026