A Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia (NCT06752668)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Auburn, Alabama — Auburn, Alabama
Age range: 18 Years to 65 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- Auburn, Alabama — Auburn, Alabama
- Chandler, Arizona — Chandler, Arizona
- Scottsdale, Arizona — Scottsdale, Arizona
- Long Beach, California — Long Beach, California
- Santa Ana, California — Santa Ana, California
- Brandon, Florida — Brandon, Florida
- Miami, Florida — Miami, Florida
- Miami, Florida — Miami, Florida
- Orlando, FL — Orlando, Florida
- Winter Park, Florida — Winter Park, Florida
- Atlanta, Georgia — Atlanta, Georgia
- Atlanta, Georgia — Atlanta, Georgia
- Riverdale, Georgia — Riverdale, Georgia
- New Orleans, Louisiana — New Orleans, Louisiana
- Newton, Massachusetts — Newton, Massachusetts
- Southfield, Michigan — Southfield, Michigan
- Sterling Heights, Michigan — Sterling Heights, Michigan
- Henderson, Nevada — Henderson, Nevada
- Denver, North Carolina — Denver, North Carolina
- Huntersville, North Carolina — Huntersville, North Carolina
- Cincinnati, Ohio — Cincinnati, Ohio
- Cleveland, OH — Cleveland, Ohio
- Dublin, Ohio — Dublin, Ohio
- Willow Grove, Pennsylvania — Willow Grove, Pennsylvania
- Columbia, South Carolina — Columbia, South Carolina
📞 Contact the Study Coordinator
Phone: (617) 468-5770
Email: CRYSTAL-1@centessa.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Narcolepsy Type 1
- A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia — Cullman, Alabama
- A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 — Cullman, Alabama
- A Long-term Extension Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia — Auburn, Alabama
- A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304) — Miami, Florida
- A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence — Colorado Springs, Colorado
Explore by condition: All Narcolepsy Type 1 clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.