NCT06843590

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

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 (Vibrance-3)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Idiopathic Hypersomnia

Interventions

Type	Name	Description
DRUG	ALKS 2680	Oral tablet containing ALKS 2680 for once daily administration
DRUG	Placebo	Oral placebo tablet for once daily administration

Timeline

• Start date: 2025-05-22
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-02-25
• Last updated: 2026-02-12

Locations

48 sites across 8 countries: United States, Australia, Belgium, Czechia, France, Italy, Netherlands, Spain

Regulatory

• FDA-regulated drug study