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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

RecruitingPhase 2, Phase 3Ages 18 Years - 70 YearsAllCentessa Pharmaceuticals (UK) Limited
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In plain words

What the trial is, and whether it could suit you

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. Orex

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria: * 18-70 years of age * Body Mass Index (BMI) within the range โ‰ฅ 17.0 and โ‰ค 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
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What it tests

  • cleminorexton
  • Placebo
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Where

23 sites
Birmingham, Alabama
Birmingham, United States
Colorado Springs, Colorado
Colorado Springs, United States
Brandon, Florida
Brandon, United States
Miami, Florida
Miami, United States
Miami, Florida
Miami, United States
Miami, Florida
Miami, United States
Miami, Florida
Miami, United States
Miami Lakes, Florida
Miami Lakes, United States

โ€ฆand 15 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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