A Randomized, Double-blind, 3-Arm Study to Evaluate Cleminorexton Compared With Placebo in Central Disorders of Hypersomnolence

What this Trial Is About

Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) are rare disorders that cause excessive daytime sleepiness, making it difficult for people to stay alert during daily activities like school, work, or driving. NT1 is often accompanied by cataplexy, a sudden loss of muscle strength triggered by strong emotions, while NT2 does not include this symptom. This research aims to evaluate the safety, tolerability, and effects of cleminorexton, a drug designed to mimic orexin, a brain protein important for wakefulness, in people with NT1 and NT2. Participants will be randomly assigned to one of several groups receiving either one of two doses of oral cleminorexton capsules or a matching placebo. The study includes groups for both NT1 and NT2 participants. The trial will examine how cleminorexton affects symptoms and how the body processes the drug. The study may later include people with idiopathic hypersomnia. This is a double-blind study, meaning neither participants nor researchers know who receives the drug or placebo. During the 12-week study, participants will undergo regular assessments including measuring how long they can stay awake using the Maintenance of Wakefulness Test, and completing sleepiness and narcolepsy severity scales. Researchers will monitor side effects, vital signs, lab tests, ECGs, and suicide risk ratings. They will also measure cleminorexton levels in the blood. Participation will last through the treatment period, with careful safety monitoring throughout.

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