A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2 (Brilliance NT2 Study 303)

What this Trial Is About

Researchers are evaluating the effects of ALKS 2680 tablets on reducing daytime sleepiness and disease symptoms in adults with Narcolepsy Type 2 (NT2). This Phase 3, randomized, double-blind, placebo-controlled study aims to measure changes in sleep latency and assess safety and efficacy compared to placebo. The study is sponsored by Alkermes, Inc. and focuses on adults aged 18 to 70 years with a confirmed diagnosis of NT2. Participants will be randomly assigned to receive one of three different daily doses of ALKS 2680 tablets or placebo tablets, taken orally for 12 weeks. The study includes a placebo comparator group to evaluate the effect of the investigational drug against no active medication. The intervention period lasts 12 weeks, during which participants take the assigned tablets daily. During the study, participants will undergo various assessments including the Maintenance of Wakefulness Test to measure sleep latency, the Epworth Sleepiness Scale, and other patient-reported and cognitive tests to evaluate fatigue, vigilance, and global impressions of disease severity. Safety will be monitored through reported adverse events up to 14 weeks. Participants' adherence to treatment and therapy for obstructive sleep apnea will be monitored, and the total duration of participation is approximately 12 weeks of treatment plus follow-up.

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