A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia
Public ClinicalTrials.gov record NCT06752668. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects With Narcolepsy and Idiopathic Hypersomnia (CRYSTAL-1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06752668
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 248 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 22, 2024
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2026
- Last update posted
- Apr 26, 2026
2024 – 2026
United States locations
- U.S. sites
- 29
- U.S. states
- 14
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Auburn, Alabama | Auburn | Alabama | 36832 | Recruiting |
| Chandler, Arizona | Chandler | Arizona | 85224 | Recruiting |
| Scottsdale, Arizona | Scottsdale | Arizona | 85253 | Recruiting |
| Long Beach, California | Long Beach | California | 90805 | Recruiting |
| Santa Ana, California | Santa Ana | California | 92705 | Recruiting |
| Brandon, Florida | Brandon | Florida | 33511 | Recruiting |
| Miami, Florida | Miami | Florida | 33155 | Recruiting |
| Miami, Florida | Miami | Florida | 33176 | Recruiting |
| Orlando, FL | Orlando | Florida | 32807 | Recruiting |
| Winter Park, Florida | Winter Park | Florida | 32789 | Recruiting |
| Atlanta, Georgia | Atlanta | Georgia | 30281 | Recruiting |
| Atlanta, Georgia | Atlanta | Georgia | 30328 | Recruiting |
| Riverdale, Georgia | Riverdale | Georgia | 30274 | Recruiting |
| New Orleans, Louisiana | New Orleans | Louisiana | 70127 | Recruiting |
| Newton, Massachusetts | Newton | Massachusetts | 02459 | Recruiting |
| Southfield, Michigan | Southfield | Michigan | 48075 | Recruiting |
| Sterling Heights, Michigan | Sterling Heights | Michigan | 48314 | Recruiting |
| Henderson, Nevada | Henderson | Nevada | 89052 | Recruiting |
| Denver, North Carolina | Denver | North Carolina | 28037 | Recruiting |
| Huntersville, North Carolina | Huntersville | North Carolina | 28078 | Recruiting |
| Cincinnati, Ohio | Cincinnati | Ohio | 45245 | Recruiting |
| Cleveland, OH | Cleveland | Ohio | 44106 | Recruiting |
| Dublin, Ohio | Dublin | Ohio | 43017 | Recruiting |
| Willow Grove, Pennsylvania | Willow Grove | Pennsylvania | 19090 | Recruiting |
| Columbia, South Carolina | Columbia | South Carolina | 29201 | Recruiting |
| North Charleston, South Carolina | North Charleston | South Carolina | 29406 | Recruiting |
| Austin, Texas | Austin | Texas | 78731 | Recruiting |
| El Paso, TX | El Paso | Texas | 79912 | Recruiting |
| San Antonio, Texas | San Antonio | Texas | 78229 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 8 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06752668, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 26, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06752668 live on ClinicalTrials.gov.