Cleminorexton for Narcolepsy Type 1 and Type 2

This study is looking into how well a medication called cleminorexton works compared to a placebo (an inactive capsule that looks the same) for people with Narcolepsy Type 1 (NT1) or Narcolepsy Type 2 (NT2). These conditions cause extreme daytime sleepiness. The main goal is to see if cleminorexton helps you stay awake longer, measured by a test called the Maintenance of Wakefulness Test (MWT) over 12 weeks. You might be able to join if you are 18 to 70 years old, have been diagnosed with NT1 or NT2, and are able to stop other medications for your condition. The study plans to enroll 222 participants.

Study design
This is an interventional study comparing cleminorexton to a placebo. It plans to enroll 222 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 12 weeks, which suggests follow-up for at least that duration.

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NCT07598708

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

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Centessa Pharmaceuticals (UK) Limited
~222 participants
Updated 2026-08-11 on ClinicalTrials.gov
What's tested:cleminorextonPlacebo

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in mean sleep latency (average of the first 4 trials) on the Maintenance of Wakefulness Test (MWT)
Measured over Baseline to week 12
Narcolepsy Type 1
Narcolepsy Type 2
15 sites across 8 states
Florida6
North Carolina2
Ohio2
Colorado1
Georgia1
Mississippi1
South Carolina1
Texas1

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Eligibility criteria

Inclusion

18-70 years of age
Body Mass Index (BMI) within the range ≥ 17.0 and ≤ 45 kg/m\^2 (inclusive)
Meets the diagnostic criteria of Narcolepsy Type 1 (NT1) or Type 2 (NT2) according to International Classification of Sleep Disorders, 3rd edition, Text Revision edition (ICSD-3-TR) criteria
Is willing and able to discontinue all medications used for the treatment of narcolepsy
Is willing and able to adhere to additional protocol requirements

Exclusion

Medical disorder other than NT1 or NT2, that is associated with excessive daytime sleepiness (EDS)
Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease
  • Change from baseline in mean sleep latency (average of the first 4 trials) on the Maintenance of Wakefulness Test (MWT)Baseline to week 12