RecruitingPhase 2Phase 3NCT07598708

A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence

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


Sponsor

Centessa Pharmaceuticals (UK) Limited

Enrollment

222 participants

Start Date

May 29, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called cleminorexton for people with narcolepsy type 1 and narcolepsy type 2. The study is currently recruiting participants at 10 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGcleminorexton

Oral cleminorexton capsule

DRUGPlacebo

matching placebo capsule


Locations(20)

Birmingham, Alabama

Birmingham, Alabama, United States

Colorado Springs, Colorado

Colorado Springs, Colorado, United States

Brandon, Florida

Brandon, Florida, United States

Miami, Florida

Miami, Florida, United States

Miami, Florida

Miami, Florida, United States

Miami, Florida

Miami, Florida, United States

Miami, Florida

Miami, Florida, United States

Miami Lakes, Florida

Miami Lakes, Florida, United States

Orlando, Florida

Orlando, Florida, United States

Atlanta, Georgia

Atlanta, Georgia, United States

Flowood Mississippi

Flowood, Mississippi, United States

Denver, North Carolina

Denver, North Carolina, United States

Huntersville, North Carolina

Huntersville, North Carolina, United States

Cincinnati, Ohio

Cincinnati, Ohio, United States

Dublin, Ohio

Dublin, Ohio, United States

Columbia, South Carolina

Columbia, South Carolina, United States

Austin, Texas

Austin, Texas, United States

Dallas, Texas

Dallas, Texas, United States

San Antonio, Texas

San Antonio, Texas, United States

Sugar Land, Texas

Sugar Land, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07598708


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