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drugset / Trial / NCT06767683

A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia

NCT06767683 ↗

Phase 2/3 Recruiting 256 enrolled Alkermes, Inc.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to continue to measure the safety, tolerability, and durability of treatment effect in subjects with Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), or Idiopathic Hypersomnia (IH) when taking ALKS 2680 tablets.

Timeline

Start
2025-01-27
Primary completion
2028-06
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject ALKS 2680 Unknown 4 mg Oral
Subject ALKS 2680 Unknown 6 mg Oral
Subject ALKS 2680 Unknown 8 mg Oral
Subject ALKS 2680 Unknown 10 mg Oral
Subject ALKS 2680 Unknown 14 mg Oral
Subject ALKS 2680 Unknown 18 mg Oral

Indications

idiopathic hypersomnia narcolepsy 1 narcolepsy without cataplexy