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Phase 2 Study to Test the Safety and Effectiveness of ALKS 2680 Tablets in Adults with Idiopathic Hypersomnia
Led by Alkermes, Inc. · Updated on 2026-06-24
126
Participants Needed
50
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the safety and impact on daytime sleepiness of ALKS 2680 in adults with Idiopathic Hypersomnia, a condition characterized by excessive sleepiness. This Phase 2 trial aims to compare different doses of ALKS 2680 with a placebo to better understand its effects on this condition. Participants receive daily oral tablets of ALKS 2680 at doses of 10 mg, 14 mg, or 18 mg, or a placebo tablet. The study uses a randomized, double-blind, parallel-group design to evaluate different dose levels over a period of up to 8 weeks. The main focus is on measuring changes in sleepiness and symptom severity. During the study, participants will be monitored for changes in their Epworth Sleepiness Scale scores and Idiopathic Hypersomnia Severity Scale scores from the start to Week 8. Researchers will also track any treatment-emergent adverse events for up to 10 weeks. Participants are expected to follow lifestyle guidelines, use actigraphy and diaries, and adhere to therapy for obstructive sleep apnea if applicable throughout the study period.
CONDITIONS
Brief Title
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
Research Team
D
Director, Global Clinical Services
D
Director, Global Clinical Services
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