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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-518929-15-00 | EU Trial (CTIS) Number |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narcolepsy Type 1: ORX750 and Placebo | Experimental |
| |
| Narcolepsy Type 2: ORX750 and Placebo | Experimental |
| |
| Idiopathic Hypersomnia: ORX750 and Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORX750 | Drug | ORX750 capsule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Up to Day 35 | |
| Number of Participants With Abnormal Changes From Baseline in Laboratory Tests | Up to Day 35 | |
| Number of Participants With Abnormal Change From Baseline in Vital Signs | Up to Day 35 | |
| Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG) | Up to Day 35 | |
| Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax: Maximum Observed Plasma Concentration for ORX750 | Day 1, 15, 28 | |
| Tmax: Time of Maximum Concentration for ORX750 | Day 1, 15, 28 | |
| AUC0last: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX750 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Centessa Pharmaceuticals | Contact | +1 617-468-5770 | CRYSTAL-1@centessa.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn, Alabama | Recruiting | Auburn | Alabama | 36832 | United States | |
| Chandler, Arizona |
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| Placebo | Drug | ORX750 matching placebo capsule. |
|
| up to Day 28 |
| Cmax,ss: Maximum Observed Concentration at Steady State for ORX750 | Day 1, 15, 28 |
| AUCτ: Area Under the Concentration-time Curve During a Dosing Interval at Steady State for ORX750 | Day 1, 15, 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 | Baseline up to Day 28 |
| Change From Baseline in Epworth Sleepiness Scale (ESS) | Baseline up to Day 28 |
| Recruiting |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Scottsdale, Arizona | Recruiting | Scottsdale | Arizona | 85253 | United States |
| Long Beach, California | Recruiting | Long Beach | California | 90805 | United States |
| Santa Ana, California | Recruiting | Santa Ana | California | 92705 | United States |
| Brandon, Florida | Recruiting | Brandon | Florida | 33511 | United States |
| Miami, Florida | Recruiting | Miami | Florida | 33155 | United States |
| Miami, Florida | Recruiting | Miami | Florida | 33176 | United States |
| Orlando, FL | Recruiting | Orlando | Florida | 32807 | United States |
| Winter Park, Florida | Recruiting | Winter Park | Florida | 32789 | United States |
| Atlanta, Georgia | Recruiting | Atlanta | Georgia | 30281 | United States |
| Atlanta, Georgia | Recruiting | Atlanta | Georgia | 30328 | United States |
| Riverdale, Georgia | Recruiting | Riverdale | Georgia | 30274 | United States |
| New Orleans, Louisiana | Recruiting | New Orleans | Louisiana | 70127 | United States |
| Newton, Massachusetts | Recruiting | Newton | Massachusetts | 02459 | United States |
| Southfield, Michigan | Recruiting | Southfield | Michigan | 48075 | United States |
| Sterling Heights, Michigan | Recruiting | Sterling Heights | Michigan | 48314 | United States |
| Henderson, Nevada | Recruiting | Henderson | Nevada | 89052 | United States |
| Denver, North Carolina | Recruiting | Denver | North Carolina | 28037 | United States |
| Huntersville, North Carolina | Recruiting | Huntersville | North Carolina | 28078 | United States |
| Cincinnati, Ohio | Recruiting | Cincinnati | Ohio | 45245 | United States |
| Cleveland, OH | Recruiting | Cleveland | Ohio | 44106 | United States |
| Dublin, Ohio | Recruiting | Dublin | Ohio | 43017 | United States |
| Willow Grove, Pennsylvania | Recruiting | Willow Grove | Pennsylvania | 19090 | United States |
| Columbia, South Carolina | Recruiting | Columbia | South Carolina | 29201 | United States |
| North Charleston, South Carolina | Recruiting | North Charleston | South Carolina | 29406 | United States |
| Austin, Texas | Recruiting | Austin | Texas | 78731 | United States |
| El Paso, TX | Recruiting | El Paso | Texas | 79912 | United States |
| San Antonio, Texas | Recruiting | San Antonio | Texas | 78229 | United States |
| Toronto, Ontario | Recruiting | Toronto | Ontario | M5S 3A3 | Canada |
| Leon, France | Recruiting | Léon | Bordeaux | 33000 | France |
| Bologna, Italy | Recruiting | Bologna | 40139 | Italy |
| Pozzilli, Italy | Recruiting | Pozzilli | 86077 | Italy |
| Verona, Italy | Recruiting | Verona | 37134 | Italy |
| Madrid, Spain | Recruiting | Madrid | 28036 | Spain |
| Madrid, Spain | Recruiting | Madrid | 28043 | Spain |
| Vitoria-Gasteiz, Spain | Recruiting | Vitoria-Gasteiz | 01009 | Spain |
| ID | Term |
|---|---|
| D020177 | Idiopathic Hypersomnia |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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