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

Description

Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) are rare conditions that make people feel very sleepy during the day (often referred to as excessive daytime sleepiness \[EDS\]). People living with these conditions might find it hard to stay alert and pay attention when they are at school, working, driving, or performing other daily activities. While all conditions result in feeling sleepy, there are some differences in other common symptoms: * NT1: People with NT1 often feel very tired during the day and experience cataplexy. Cataplexy is a sudden loss of muscle strength, which can cause someone to collapse or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise. They may also have trouble sleeping well at night. * NT2: People with NT2 feel sleepy during the day, just like NT1, but they do not have cataplexy. Orexin is a protein in the brain that helps coordinate a system that plays an important role in helping people to stay awake during the daytime. Cleminorexton is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable cleminorexton is in NT1 and NT2 and learn about what the drug does to the body. Another goal of the study is to see if cleminorexton can help people with NT1 and NT2 feel less sleepy and make other symptoms better.

Interventions

• cleminorexton (Drug)
  Oral cleminorexton capsule
• Placebo (Drug)
  matching placebo capsule

Eligibility criteria

Conditions

Locations

• Birmingham, Alabama — Birmingham, Alabama, United States
• Colorado Springs, Colorado — Colorado Springs, Colorado, United States
• Brandon, Florida — Brandon, Florida, United States
• Miami, Florida — Miami, Florida, United States
• Miami, Florida — Miami, Florida, United States
• Miami, Florida — Miami, Florida, United States
• Miami, Florida — Miami, Florida, United States
• Miami Lakes, Florida — Miami Lakes, Florida, United States
• Orlando, Florida — Orlando, Florida, United States
• St. Petersburg, Florida — St. Petersburg, Florida, United States
• Atlanta, Georgia — Atlanta, Georgia, United States
• Rincon, Georgia — Rincon, Georgia, United States
• Flowood Mississippi — Flowood, Mississippi, United States
• Denver, North Carolina — Denver, North Carolina, United States
• Huntersville, North Carolina — Huntersville, North Carolina, United States
• Cincinnati, Ohio — Cincinnati, Ohio, United States
• Dublin, Ohio — Dublin, Ohio, United States
• Columbia, South Carolina — Columbia, South Carolina, United States
• Austin, Texas — Austin, Texas, United States
• Dallas, Texas — Dallas, Texas, United States
• Houston, Texas — Houston, Texas, United States
• San Antonio, Texas — San Antonio, Texas, United States
• Sugar Land, Texas — Sugar Land, Texas, United States