drugset / Trial / NCT06358950

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)

NCT06358950 ↗

Phase 2 Completed 92 enrolled Alkermes, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this research study is to assess the safety and efficacy of ALKS 2680 compared to placebo, including whether participants taking ALKS 2680 experience a greater decrease in sleepiness and a decrease in cataplexy ("sudden loss of muscle control"), compared to participants taking placebo alone.

Timeline

Start
2024-03-24
Primary completion
2025-06-19
Completion
2025-07-31

Outcome

Met primary endpoint

release “In Vibrance-1, alixorexton met the primary endpoint across all doses tested” alkermes.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ALKS 2680 Unknown 4 mg Oral
Subject ALKS 2680 Unknown 6 mg Oral
Subject ALKS 2680 Unknown 8 mg Oral

Indications