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

Part of paid clinical trials in Columbia, South Carolina.

Sponsor
Centessa Pharmaceuticals (UK) Limited
Study ID
NCT07598708
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Narcolepsy Type 1
  • Narcolepsy Type 2

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • cleminorexton — DRUG
    Oral cleminorexton capsule
  • Placebo — DRUG
    matching placebo capsule

Study Details

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.

Key Dates

Start date
May 15, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
222 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A - Narcolepsy Type 1 (Dose 1)
  • Experimental: Group A - Narcolepsy Type 1 (Dose 2)
  • Placebo Comparator: Group A - Narcolepsy Type 1 (placebo)
  • Experimental: Group B - Narcolepsy Type 2 (Dose 1)
  • Experimental: Group B - Narcolepsy Type 2 (Dose 2)
  • Placebo Comparator: Group B - Narcolepsy Type 2 (placebo)

Primary Outcome Measure

Change from baseline in mean sleep latency (average of the first 4 trials) on the Maintenance of Wakefulness Test (MWT) [ Time Frame: Baseline to week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIP
Columbia, South CarolinaColumbiaSouth Carolina29201

Find similar trials in Columbia, SC

By research site
Columbia, South Carolina· Columbia, SC

Related Studies