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This study is a long-term extension (LTE) of the parent Study ORX750 0201, and will provide long-term open-label safety, tolerability, and efficacy of ORX750 in participants with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Narcolepsy Type 1 | Experimental | Narcolepsy Type 1 (Open Label) |
|
| Narcolepsy Type 2 | Experimental | Narcolepsy Type 2 (Open Label) |
|
| Idiopathic Hypersomnia | Experimental | Idiopathic Hypersomnia (Open Label) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ORX750 | Drug | Oral ORX750 |
| |
| ORX750 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs | Up to day 70 |
| Abnormal Laboratory Tests | Number of Participants With Abnormal Changes From Baseline in Laboratory Tests | Up to day 70 |
| Abnormal Vital Signs | Number of Participants With Abnormal Change From Baseline in Vital Signs | Up to day 70 |
| Abnormal ECG | Number of Participants With Abnormal Change From Baseline in Electrocardiograms (ECG) | Up to day 70 |
| Suicidal Ideation or Behavior | Number of Participants With Suicidal Ideation or Suicidal Behavior as Measured Using Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Cmax: Maximum Observed Plasma Concentration for ORX750 | Up to day 63 |
| Tmax | Tmax: Time of Maximum Concentration for ORX750 | Up to day 63 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Orexin Centessa Program Lead | Contact | 617-468-5770 | ORX750-LTE@centessa.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Auburn, alabama | Recruiting | Auburn | Alabama | 36832 | United States | |
| Santa Ana, California |
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Open Label Long Term Extension Study
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| Drug |
Oral ORX750 |
|
| ORX750 | Drug | Oral ORX750 |
|
| AUClast | AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for ORX750 | Up to day 63 |
| Cmax,ss | Cmax,ss: Maximum Observed Concentration at Steady State for ORX750 | Up to day 63 |
| AUCτ | AUCτ: Area Under the Concentration-time Curve During a Dosing Interval at Steady State for ORX750 | Up to day 63 |
| Maintenance of Wakefulness Test | Change From Baseline in Mean sleep latency (average of the first 4 trials) in the Maintenance of Wakefulness Test (MWT) | Up to day 63 |
| Epworth Sleepiness Scale | Change From Baseline in Epworth Sleepiness Scale (ESS) | Up to day 63 |
| Recruiting |
| Santa Ana |
| California |
| 92705 |
| United States |
| Miami, Florida | Recruiting | Miami | Florida | 33176 | United States |
| Orlando, Florida | Recruiting | Orlando | Florida | 32807 | United States |
| Winter Park, FL | Recruiting | Winter Park | Florida | 32789 | United States |
| Stockbridge, GA | Recruiting | Atlanta | Georgia | 30281 | United States |
| Atlanta, Georgia | Recruiting | Atlanta | Georgia | 30328 | United States |
| Sterling Heights, Michigan | Recruiting | Sterling Heights | Michigan | 48314 | United States |
| Hendersen, Navada | Recruiting | Henderson | Nevada | 89052 | 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 | 28070 | United States |
| Cincinnati, Ohio | Recruiting | Cincinnati | Ohio | 45245 | United States |
| Dublin | Recruiting | Dublin | Ohio | 43017 | United States |
| Abington, Pennsylvania | Recruiting | Abington | Pennsylvania | 19046 | United States |
| Willow Grove, Pennsylvania | Recruiting | Willow Grove | Pennsylvania | 19090 | United States |
| North Charleston, South Carolina | Recruiting | North Charleston | South Carolina | 29406-9196 | United States |
| Austin, Texas | Recruiting | Austin | Texas | 30328 | United States |
| El Paso, Texas | Recruiting | El Paso | Texas | 79912 | United States |
| Toronto | Recruiting | Toronto | Ontario | M5S 3A3 | Canada |
| Bologna | Recruiting | Bologna | BO | 40139 | Italy |
| Verona | Recruiting | Verona | VR | 37134 | Italy |
| Móstoles, Madrid | Recruiting | Móstoles | Madrid | 28938 | Spain |
| Álava, Spain | Recruiting | Álava | 01004 | Spain |
| ID | Term |
|---|---|
| D020177 | Idiopathic Hypersomnia |
| D009290 | Narcolepsy |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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