A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
Purpose
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.
Conditions
- Narcolepsy Type 1
- Narcolepsy Type 2
- Idiopathic Hypersomnia
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18-65 years of age - BMI ≥17 and ≤37 kg/m2 - Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria - Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia - Is willing and able to adhere to additional protocol requirements
Exclusion Criteria
- A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS). - Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Narcolepsy Type 1: ORX750 and Placebo |
|
|
|
Experimental Narcolepsy Type 2: ORX750 and Placebo |
|
|
|
Experimental Idiopathic Hypersomnia: ORX750 and Placebo |
|
Recruiting Locations
Auburn 4830796, Alabama 4829764 36832
Chandler 5289282, Arizona 5551752 85224
Scottsdale 5313457, Arizona 5551752 85253
Long Beach 5367929, California 5332921 90805
Santa Ana 5392900, California 5332921 92705
Brandon 4148757, Florida 4155751 33511
Miami 4164138, Florida 4155751 33155
Miami 4164138, Florida 4155751 33176
Orlando 4167147, Florida 4155751 32807
Winter Park 4178560, Florida 4155751 32789
Atlanta 4180439, Georgia 4197000 30281
Atlanta 4180439, Georgia 4197000 30328
Riverdale 4219001, Georgia 4197000 30274
New Orleans 4335045, Louisiana 4331987 70127
Newton 4945283, Massachusetts 6254926 02459
Southfield 5010636, Michigan 5001836 48075
Sterling Heights 5011148, Michigan 5001836 48314
Henderson 5505411, Nevada 5509151 89052
Denver 4463523, North Carolina 4482348 28037
Huntersville 4472370, North Carolina 4482348 28078
Cincinnati 4508722, Ohio 5165418 45245
Cleveland 5150529, Ohio 5165418 44106
Dublin 5152333, Ohio 5165418 43017
Willow Grove 5219619, Pennsylvania 6254927 19090
Columbia 4575352, South Carolina 4597040 29201
North Charleston 4589387, South Carolina 4597040 29406
Austin 4671654, Texas 4736286 78731
San Antonio 4726206, Texas 4736286 78229
More Details
- NCT ID
- NCT06752668
- Status
- Recruiting
- Sponsor
- Centessa Pharmaceuticals (UK) Limited