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

Phase 2

Recruiting

• Conditions: Idiopathic Hypersomnia
• Interventions: Drug: Placebo; Drug: ALKS 2680

• Registration Number: NCT06843590
• Lead Sponsor: Alkermes, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-21
• Study First Posted: 2025-02-25
• Study Start: 2025-04-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-04
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral placebo tablet for once daily administration
ALKS 2680, 10 mg	ALKS 2680	Oral tablet containing 10 mg of ALKS 2680 for once daily administration
ALKS 2680, 14 mg	ALKS 2680	Oral tablet containing 14 mg of ALKS 2680 for once daily administration
ALKS 2680, 18 mg	ALKS 2680	Oral tablet containing 18 mg of ALKS 2680 for once daily administration

Primary Outcome Measures

Name	Time	Method
Change in Epworth Sleepiness Scale (ESS) from baseline to Week 8 by dose level	Up to 8 weeks

Secondary Outcome Measures

Name	Time	Method
Change in Idiopathic Hypersomnia Severity Scale (IHSS) from baseline to Week 8 by dose level	Up to 8 weeks

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 San Antonio, Texas, United States