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Study of tasimelteon compared to placebo for treating insomnia in children

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What is this trial about?

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

This study focuses on children and teenagers with Insomnia Disorder, a condition that makes it difficult to fall asleep at night. The research examines a medicine called tasimelteon, which is given as a liquid that can be taken by mouth. The study aims to determine if tasimelteon helps children and teenagers fall asleep more quickly compared to a placebo.

During the study, participants will be divided into two groups. One group will receive tasimelteon as an oral liquid suspension, while the other group will receive a placebo liquid that looks exactly the same. The treatment will continue for 12 months, with participants taking their assigned medication daily. The amount of medicine given will be based on the participant's weight, but will not exceed 20 milligrams per day.

Throughout the study, information about sleep patterns will be collected through daily sleep diaries that participants and their caregivers will need to complete. Various aspects of sleep and daily functioning will be monitored, including how long it takes to fall asleep and how well participants feel during the day. The study will also look at how the medicine affects the youngest participants who are two years old.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your sleep patterns will be evaluated to confirm a diagnosis of insomnia disorder.

    You will need to document your sleep patterns in a Daily Sleep Diary for at least 5 out of 7 nights during the screening period.

    Your sleep difficulties should include taking 1 hour or longer to fall asleep at least 4 nights per week for the past 3 months.

  2. Step 2

    Random assignment to treatment

    You will be randomly assigned to receive either tasimelteon or a placebo (inactive substance).

    Neither you nor the medical staff will know which treatment you are receiving.

    Both the active medication and placebo will be in liquid form and will look identical.

  3. Step 3

    Daily treatment and monitoring

    You will take the assigned liquid medication by mouth daily.

    You must continue maintaining a Daily Sleep Diary to track your sleep patterns.

    Your sleep will be monitored using a special device called an actigraph that records sleep-wake patterns.

  4. Step 4

    Regular assessments

    Your progress will be evaluated using various questionnaires about sleep and daily functioning.

    Both you and your caregiver will complete assessments about changes in your sleep and behavior.

    If you are 2 years old, additional blood samples will be taken to measure how the medication moves through your body.

  5. Step 5

    Study completion

    The study will continue until enough data is collected to evaluate the medication's effectiveness.

    The main focus will be on measuring how long it takes you to fall asleep.

    Additional assessments will look at overall sleep quality and daytime functioning.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of insomnia disorder (difficulty falling or staying asleep)
  • Must take at least 1 hour to fall asleep on average 4 nights per week for at least 3 months before screening
  • Must have documented evidence of taking 1 hour or more to fall asleep at least 3 nights per week in the 4 weeks before starting the study (recorded in a sleep diary)
  • Sleep problems must not be caused by medications
  • Must be between 2 and 17 years old at the first visit
  • Must have parent/legal guardian consent and child's agreement (assent) to participate
  • Must complete a Daily Sleep Diary (a record of sleep patterns) for at least 5 out of 7 nights during the screening period
  • Both the child and parent/guardian must be willing and able to follow all study requirements and restrictions

Who cannot join the trial?

14 criteria

  • People under 18 years old
  • History of sleep apnea (a condition where breathing repeatedly stops and starts during sleep)
  • Current or past diagnosis of narcolepsy (a condition causing sudden daytime sleepiness)
  • Working night shifts or irregular work schedules that affect sleep patterns
  • Use of prescription medications that may affect sleep in the past 2 weeks
  • Current use of sleep medications or supplements
  • History of substance abuse or alcohol dependency
  • Severe psychiatric conditions that could impact sleep
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the past 30 days
  • Significant medical conditions that could interfere with the study results
  • Known allergies to the study medication or similar compounds
  • Irregular sleep schedule or inability to maintain regular sleep times
  • Caffeine consumption exceeding 4 cups of coffee per day
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Investigated drugs

  • Tasimelteon

    is a medication used to treat sleep disorders. It works by regulating the body's natural sleep-wake cycle (also known as circadian rhythm). This medication helps people who have difficulty falling asleep by mimicking the effects of melatonin, a natural hormone in the body that helps control sleep patterns. It is particularly being studied for its effectiveness in treating insomnia in children and adolescents.

  • Placebo

    is an inactive substance that looks identical to the real medication but contains no active ingredients. It is used as a control in clinical trials to help determine if the actual medication being tested is effective.

What is already known about the treatment

Tasimelteon - A prescription sleep medication administered orally that works by mimicking the effects of melatonin, a natural hormone that regulates sleep-wake cycles in the body. This medication belongs to the class of melatonin receptor agonists and is primarily used to treat insomnia disorder by helping people fall asleep faster and regulate their sleep patterns. Tasimelteon works by binding to specific receptors (MT1 and MT2) in the brain that are involved in maintaining the body's natural circadian rhythm, making it particularly effective for sleep disorders that involve disrupted sleep timing. The medication has been clinically proven effective in adults and is currently being studied in pediatric populations through controlled clinical trials.

Investigated diseases

Insomnia Disorder - A sleep condition characterized by persistent difficulty in falling asleep, staying asleep, or both, despite having adequate opportunity for sleep. People with this disorder often experience poor sleep quality that affects their daytime functioning. The condition can result in fatigue, difficulty concentrating, mood disturbances, and decreased performance in daily activities. Insomnia can be experienced as trouble falling asleep at the beginning of the night, frequent or prolonged awakenings during the night, or early-morning awakening with an inability to return to sleep. The disorder can develop independently or may be associated with changes in sleep schedule, stress, or other factors.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-516411-24-00Protocol codeVP-VEC-162-3108Estimated enrolment460 patientsSponsorVanda Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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