Study of Cleminorexton Compared to Placebo for Treating Narcolepsy Type 1 and Type 2 in Adults Aged 18 to 70

What this Trial Is About

Narcolepsy Type 1 NT1 and Narcolepsy Type 2 NT2 are rare conditions causing excessive daytime sleepiness, affecting alertness during daily activities like school, work, or driving. NT1 also involves episodes of sudden muscle weakness called cataplexy, often triggered by strong emotions, while NT2 lacks this symptom. Researchers aim to study cleminorexton, a drug designed to mimic the brain protein orexin, to evaluate its safety, tolerability, and potential to reduce sleepiness and improve symptoms in people with NT1 and NT2. Participants in this study are randomly assigned to receive either one of two doses of oral cleminorexton capsules or a matching placebo. The study includes separate groups for NT1 and NT2, and the treatment period lasts 12 weeks. Future protocol amendments may add a group for idiopathic hypersomnia. Throughout the study, participants will discontinue other narcolepsy medications and follow specific protocol requirements. During the trial, participants will be closely monitored through various assessments including the Maintenance of Wakefulness Test to measure changes in sleepiness, the Epworth Sleepiness Scale, and cataplexy frequency. Safety evaluations involve laboratory tests, vital signs, electrocardiograms, and monitoring for adverse events or suicidal thoughts. The study will track how the drug behaves in the body and measure outcomes over 12 weeks to understand its effects on narcolepsy symptoms and overall participant health.

A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence