Study of tasimelteon compared to placebo for treating insomnia in children

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centrum Medyczne “Hipokrates” s.c. Elżbieta i Grzegorz Grześk	Bydgoszcz	Poland

Other Sites

Site Name	City	Country
Clinical Research Center Sp. z o.o. Medic-R sp.k.	Poznan	Poland
Linden Sp. z o.o. sp.k.	Cracow	Poland
Clinmedica Research sp. z o.o.	Skierniewice	Poland
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Advanced Sleep Research GmbH	Berlin	Germany
Wojewódzki Szpital Psychiatryczny im. prof. Tadeusza Bilikiewicza	Gdansk	Poland
Gbphkfpzro Rhbhhrke Sbc z ohhj	Wroclaw	Poland
Cvrtivp Bydjz Kblxmhxjzkm Pyqgiuqs Sxl z oaqo	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	20.02.2026
Poland	Recruiting	20.02.2026

Trial locations

Investigated drugs:

Tasimelteon

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.

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 ID:

2024-516411-24-00

Protocol code:

VP-VEC-162-3108

NCT ID:

NCT06953869

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of tasimelteon compared to placebo for treating insomnia in children

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?