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

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Minor Trial sites expanded: 20 → 23 locations
    • Eligibility criteria expanded, about 7 words
  2. Minor Trial sites expanded: 15 → 20 locationsv8
  3. Minor Trial sites expanded: 10 → 15 locationsv7
  4. Minor Trial sites expanded: 7 → 10 locationsv6
  5. Minor Study sites: 5 to 7v5
  6. Minor Trial sites expanded: 2 → 5 locations
    • Start date changed from estimate of May 15, 2026 to May 29, 2026
    v4
  7. Minor Study sites: 1 to 2v3
  8. Notable Recruitment opened
    • Study sites: 0 to 1
    v2
  9. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07598708
Lead Sponsor Centessa Pharmaceuticals (UK) Limited
Conditions
(from sponsor)
Narcolepsy Type 1, Narcolepsy Type 2
Related terms Cataplexy, Disorders of Excessive Somnolence, Dyssomnias, Mental Disorders, Narcolepsy, Nervous System Diseases, Sleep Wake Disorders, Sleepiness
Enrollment 222 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov