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Study on Daridorexant for Treating Bedwetting in Adolescents

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines the effectiveness of daridorexant in treating adolescents with nocturnal enuresis, a condition characterized by involuntary urination during sleep (bedwetting) that occurs at least three times per week. The research will test if this medication can help reduce the frequency of bedwetting episodes in teenagers aged 15-17 who have not responded to standard treatments like alarm systems or desmopressin.

The investigation is designed as a randomized, double-blind, placebo-controlled study, which means some participants will receive the actual medication while others will receive a placebo, with neither the participants nor the researchers knowing who receives which treatment during the study. Researchers will monitor changes in the number of wet nights per week, measure the amount of urine produced at night, assess bladder capacity, and track any side effects that may occur.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Assignment

    You will be randomly assigned to receive either daridorexant (QUVIVIQ 25 mg film-coated tablets) or a placebo (a tablet that looks identical but contains no active medication).

    This assignment is done in a double-blind manner, meaning neither you nor the study doctors will know which treatment you are receiving.

  2. Step 2

    Treatment Period

    You will take one film-coated tablet daily throughout the study period.

    The tablet is gray and convex in shape.

    You will need to keep track of your wet nights (episodes of bedwetting) during this period.

  3. Step 3

    Monitoring and Measurements

    Throughout the study, several measurements will be taken:

    The number of wet nights per week (this is the main measurement).

    Your nocturnal urine production (the amount of urine your body produces while you sleep).

    Your bladder capacity (the maximum amount of urine your bladder can hold).

    Your nocturnal bladder capacity (how much your bladder can hold during nighttime).

  4. Step 4

    Safety Monitoring

    During the study, any adverse events (side effects or negative reactions) will be recorded.

    Your overall health will be monitored throughout the study period.

    If you experience concerning side effects, the medical team may discuss whether you should continue in the study.

  5. Step 5

    Response Assessment

    Your response to the treatment will be evaluated as either:

    Full response: A significant reduction in wet nights.

    Partial response: Some improvement but not complete resolution of enuresis (bedwetting).

    No response: Little to no change in bedwetting frequency.

  6. Step 6

    Study Completion

    The study is expected to run until August 2025, though your individual participation may be shorter.

    At the end of your participation, you will stop taking the study medication.

    A final assessment will be conducted to evaluate the overall effects of the treatment.

Who can join the trial?

5 criteria

  • You must be between 15 and 17 years old.
  • You must have primary nocturnal enuresis (bedwetting during sleep at night) with at least 3 wet nights per week.
  • You must have tried alarm treatment for at least eight weeks without success, OR
  • You must have tried desmopressin treatment (a medication that reduces urine production) for at least two weeks without success, OR
  • You must have a medical reason why you cannot use either alarm treatment or desmopressin.

Who cannot join the trial?

9 criteria

  • You cannot participate if you have nocturnal enuresis (bedwetting at night) caused by another medical condition like urinary tract infection, diabetes, or neurological disorders.
  • You cannot join if you have a history of seizures (fits where your body shakes uncontrollably).
  • If you have a history of substance abuse (addiction to drugs or alcohol) within the past 2 years, you cannot participate.
  • You cannot take part if you have severe psychiatric disorders (serious mental health conditions).
  • If you have taken certain medications that might interfere with the study drug within 1 month before the study starts, you cannot join.
  • You cannot participate if you have significant liver or kidney problems.
  • If you have participated in another clinical trial within the past 3 months, you cannot join this study.
  • You cannot take part if you are pregnant, breastfeeding, or planning to become pregnant during the study period.
  • If you have any condition that the study doctor believes would make it unsafe for you to participate, you will be excluded.
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Investigated drugs

  • Daridorexant

    is a medication that affects sleep patterns. It works by blocking certain receptors in the brain that are involved in wakefulness. In this study, it's being tested to see if it can help adolescents with enuresis (bedwetting during sleep).

  • Placebo

    is an inactive substance that looks like the real medication but contains no active ingredients. It's used as a comparison to determine if the active medication (daridorexant) provides a real benefit.

What is already known about the treatment

Daridorexant – A sleep medication administered orally in tablet form that works by blocking orexin receptors in the brain, which helps regulate the sleep-wake cycle. Daridorexant is FDA-approved for treating insomnia in adults and is currently being investigated for potential use in adolescents with nocturnal enuresis (bedwetting). It belongs to the class of dual orexin receptor antagonists (DORAs) that promote sleep by reducing excessive wakefulness rather than sedating the brain. This medication is thought to potentially help with bedwetting by improving sleep architecture and reducing nighttime arousals, though its effectiveness for this specific indication is still being evaluated in clinical trials.

Investigated diseases

Nocturnal enuresis is a condition characterized by involuntary urination during sleep at night, occurring in individuals who are at an age when bladder control would typically be expected. It involves the inability to control urination during nighttime sleep, commonly known as bedwetting. Nocturnal enuresis can be classified as primary (when a child has never achieved consistent nighttime dryness) or secondary (when bedwetting resumes after a period of dryness). The condition may result from delayed maturation of bladder control mechanisms, excessive nighttime urine production, reduced functional bladder capacity, or arousal difficulties. Nocturnal enuresis often improves with age as neurological development progresses.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2025-521443-20-00Estimated enrolment20 patientsSponsorRegion Midtjylland

sourced from the EU Clinical Trials Register and site verification

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