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. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
Auburn, Alabama
Auburn, Alabama, United States
RECRUITINGChandler, Arizona
Chandler, Arizona, United States
RECRUITINGScottsdale, Arizona
Scottsdale, Arizona, United States
RECRUITINGLong Beach, California
Long Beach, California, United States
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: Up to Day 49
Number of Participants With Abnormal Changes From Baseline in Laboratory Tests
Time frame: Up to Day 49
Number of Participants With Abnormal Change From Baseline in Vital Signs
Time frame: Up to Day 49
Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG)
Time frame: Up to Day 49
Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 49
Cmax: Maximum Observed Plasma Concentration for ORX750
Time frame: Day 1
Tmax: Time of Maximum Concentration for ORX750
Time frame: Days 1, 14 and 28
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX750
Time frame: Day 1
Cmax,ss: Maximum Observed Concentration at Steady State for ORX750
Time frame: Days 14 and 28
AUCτ: Area Under the Concentration-time Curve During a Dosing Interval at Steady State for ORX750
Time frame: Days 14 and 28
Mean sleep latency (average of the first 4 trials) in the Maintenance of Wakefulness Test (MWT) for ORX750 versus placebo.
Mean sleep latency is determined by averaging the time to falling asleep across trials
Time frame: Baseline up to Day 42
Change From Baseline in Epworth Sleepiness Scale (ESS)
Time frame: Baseline up to Day 41
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Santa Ana, California
Santa Ana, California, United States
RECRUITINGBrandon, Florida
Brandon, Florida, United States
RECRUITINGMiami, Florida
Miami, Florida, United States
RECRUITINGMiami, Florida
Miami, Florida, United States
RECRUITINGOrlando, FL
Orlando, Florida, United States
RECRUITINGWinter Park, Florida
Winter Park, Florida, United States
RECRUITING...and 19 more locations