A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
Start Date
12/23/2024
Completion Date
12/1/2026
Summary
Narcolepsy Type 1 (NT1), Narcolepsy Type 2 (NT2), and Idiopathic Hypersomnia (IH) 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. * IH: People with IH feel tired during the day, even after sleeping a lot at night. They may sleep for long periods, take long naps, and find it hard to wake up. 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 (also known as ORX750) is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable ORX750 is in NT1, NT2, and IH, and learn about what the drug does to the body. Another goal of the study is to see if ORX750 can help people with NT1, NT2, and IH feel less sleepy and make other symptoms better.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
ORX750
Placebo
Conditions
Locations
Auburn, Alabama
Auburn, Alabama 36832
United States
Chandler, Arizona
Chandler, Arizona 85224
United States
Scottsdale, Arizona
Scottsdale, Arizona 85253
United States
Long Beach, California
Long Beach, California 90805
United States
Santa Ana, California
Santa Ana, California 92705
United States
Brandon, Florida
Brandon, Florida 33511
United States
Miami, Florida
Miami, Florida 33155
United States
Miami, Florida
Miami, Florida 33176
United States
Orlando, FL
Orlando, Florida 32807
United States
Winter Park, Florida
Winter Park, Florida 32789
United States
Atlanta, Georgia
Atlanta, Georgia 30281
United States
Atlanta, Georgia
Atlanta, Georgia 30328
United States
Riverdale, Georgia
Riverdale, Georgia 30274
United States
New Orleans, Louisiana
New Orleans, Louisiana 70127
United States
Newton, Massachusetts
Newton, Massachusetts 02459
United States
Southfield, Michigan
Southfield, Michigan 48075
United States
Sterling Heights, Michigan
Sterling Heights, Michigan 48314
United States
Henderson, Nevada
Henderson, Nevada 89052
United States
Denver, North Carolina
Denver, North Carolina 28037
United States
Huntersville, North Carolina
Huntersville, North Carolina 28078
United States
Cincinnati, Ohio
Cincinnati, Ohio 45245
United States
Cleveland, OH
Cleveland, Ohio 44106
United States
Dublin, Ohio
Dublin, Ohio 43017
United States
Willow Grove, Pennsylvania
Willow Grove, Pennsylvania 19090
United States
Columbia, South Carolina
Columbia, South Carolina 29201
United States
North Charleston, South Carolina
North Charleston, South Carolina 29406
United States
Austin, Texas
Austin, Texas 78731
United States
El Paso, TX
El Paso, Texas 79912
United States
San Antonio, Texas
San Antonio, Texas 78229
United States
Toronto, Ontario
Toronto, Ontario M5S 3A3
Canada
Leon, France
Léon, Bordeaux 33000
France
Bologna, Italy
Bologna, 40139
Italy
Pozzilli, Italy
Pozzilli, 86077
Italy
Verona, Italy
Verona, 37134
Italy
Madrid, Spain
Madrid, 28036
Spain
Madrid, Spain
Madrid, 28043
Spain
Vitoria-Gasteiz, Spain
Vitoria-Gasteiz, 01009
Spain