A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence (NCT07598708)
A Randomized, Double-blind, 3-Arm Parallel Design Study to Investigate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Cleminorexton Compared With Placebo in Participants With Central Disorders of Hypersomnolence
🩺 Plain-English Summary (8th-Grade Level)
Narcolepsy Type 1 (NT1) and Narcolepsy Type 2 (NT2) 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. 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 is designed to mimic the action of orexin. The purpose of this study is to see how safe and tolerable cleminorexton is in NT1 and NT2 and learn about what the drug does to the body. Another goal of the study is to see if cleminorexton can help people with NT1 and NT2 feel less sleepy and make other symptoms better.
Who can join: Review the eligibility criteria below.
Location: Colorado Springs, Colorado — Colorado Springs, Colorado
Age range: 18 Years to 70 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 (15 Sites)
- Colorado Springs, Colorado — Colorado Springs, Colorado
- Miami, Florida — Miami, Florida
- Miami, Florida — Miami, Florida
- Miami, Florida — Miami, Florida
- Miami, Florida — Miami, Florida
- Miami Lakes, Florida — Miami Lakes, Florida
- Orlando, Florida — Orlando, Florida
- Atlanta, Georgia — Atlanta, Georgia
- Flowood Mississippi — Flowood, Mississippi
- Denver, North Carolina — Denver, North Carolina
- Huntersville, North Carolina — Huntersville, North Carolina
- Cincinnati, Ohio — Cincinnati, Ohio
- Dublin, Ohio — Dublin, Ohio
- Columbia, South Carolina — Columbia, South Carolina
- Sugar Land, Texas — Sugar Land, Texas
📞 Contact the Study Coordinator
Phone: (617) 468-5770
Email: ORX750trials@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 Study of ORX750 in Participants With Narcolepsy and Idiopathic Hypersomnia — Auburn, 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
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.