Phase 3 Study to Test ALKS 2680 Tablets for Treating Adults with Narcolepsy Type 2

What this Trial Is About

Researchers are evaluating the effects of ALKS 2680 tablets on adults with Narcolepsy Type 2 NT2. This Phase 3 study aims to measure changes in daytime sleepiness and overall disease symptoms by comparing ALKS 2680 with placebo tablets. The trial focuses on assessing how the treatment impacts participants ability to stay awake and their symptom severity over time. Participants will be randomly assigned to one of four groups three different doses of ALKS 2680 tablets or placebo tablets. All tablets are taken daily by mouth for 12 weeks. The study uses a triple-blind design to fairly compare the effects of ALKS 2680 against placebo. The treatment period lasts for 12 weeks, during which participants take their assigned tablets regularly. During the study, participants undergo various assessments including the Maintenance of Wakefulness Test to measure sleep latency, the Epworth Sleepiness Scale, and other cognitive and fatigue-related questionnaires. Researchers monitor changes from baseline to Week 12 to evaluate treatment effects. Safety is also tracked through reports of any adverse events. Overall, participants are involved for about 12 weeks of treatment and follow-up assessments.

A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2