Test of Cleminorexton vs placebo for central hypersomnolence in NT1/NT2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates cleminorexton for adults with NT1 or NT2 who experience excessive daytime sleepiness. Participants are assigned to receive cleminorexton or placebo across phase 2 and phase 3 cohorts. Key criteria include age 18–70, BMI 17–45, and adherence to narcolepsy diagnostic standards, with requirements to stop other narcolepsy medications during the study. The trial may later expand to include idiopathic hypersomnia in a future amendment. Primary outcomes focus on wakefulness and symptom improvement, with safety monitoring throughout.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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

Where it's running

• Birmingham, Alabama
  Birmingham, Alabama, United States Recruiting
• Colorado Springs, Colorado
  Colorado Springs, Colorado, United States Recruiting
• Brandon, Florida
  Brandon, Florida, United States Recruiting
• Miami, Florida
  Miami, Florida, United States Recruiting
• Miami, Florida
  Miami, Florida, United States Recruiting
• Miami, Florida
  Miami, Florida, United States Recruiting

Study contacts

• Study coordinator: Centessa Pharmaceuticals
• Email: ORX750trials@centessa.com
• Phone: 617-468-5770

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.