A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Public ClinicalTrials.gov record NCT07598708. 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 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07598708
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 222 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 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
- May 28, 2026
- Primary completion
- Sep 29, 2027
- Completion
- Dec 30, 2027
- Last update posted
- Aug 10, 2026
2026 – 2027
United States locations
- U.S. sites
- 15
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Colorado Springs, Colorado | Colorado Springs | Colorado | 80918 | Recruiting |
| Miami, Florida | Miami | Florida | 33155 | Recruiting |
| Miami, Florida | Miami | Florida | 33166 | Recruiting |
| Miami, Florida | Miami | Florida | 33176 | Recruiting |
| Miami, Florida | Miami | Florida | 33186 | Recruiting |
| Miami Lakes, Florida | Miami Lakes | Florida | 33014 | Recruiting |
| Orlando, Florida | Orlando | Florida | 32807 | Recruiting |
| Atlanta, Georgia | Atlanta | Georgia | 30328 | Recruiting |
| Flowood Mississippi | Flowood | Mississippi | 39232 | Recruiting |
| Denver, North Carolina | Denver | North Carolina | 28037 | Recruiting |
| Huntersville, North Carolina | Huntersville | North Carolina | 28078 | Recruiting |
| Cincinnati, Ohio | Cincinnati | Ohio | 45245 | Recruiting |
| Dublin, Ohio | Dublin | Ohio | 43017 | Recruiting |
| Columbia, South Carolina | Columbia | South Carolina | 29201 | Recruiting |
| Sugar Land, Texas | Sugar Land | Texas | 77478 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07598708, 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 Aug 10, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07598708 live on ClinicalTrials.gov.