RecruitingPHASE3INTERVENTIONAL

Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

This research is investigating a new medicine, tasimelteon, for children and teenagers between 2 and 17 years old who have trouble sleeping. The study aims to find out if tasimelteon is an effective and safe treatment for insomnia. Some participants will receive the active medicine, while others will receive a placebo (a dummy medicine with no active ingredients). This is a 'double-blind' study, meaning neither the participants nor their doctors will know who is getting which treatment until the study ends. This helps ensure the results are as fair and unbiased as possible. The goal is to see if tasimelteon can help young people get a better night's sleep.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Vanda Pharmaceuticals

Enrolment target

420

Start

21 Apr 2025

Estimated completion

01 Jan 2028

Insomnia Disorder

What is this study about?

This study is looking into a new medicine called tasimelteon, specifically designed for children and teenagers aged 2 to 17 who are experiencing ongoing sleep difficulties, known as insomnia. Insomnia means having trouble falling asleep, staying asleep, or getting enough restful sleep, which can affect daily life.

The main goal of this research is to see if tasimelteon can effectively help these young people sleep better and if it is safe to use. To do this, some participants will be given tasimelteon, while others will receive a 'placebo', which looks exactly like the medicine but contains no active ingredients. Comparing the two groups helps researchers understand if any improvements are due to the medicine itself or other factors.

This is a 'Phase 3' study, which means the medicine has already been tested in smaller groups and shown some promise. This larger study is a crucial step before the medicine could potentially be made available more widely. By participating, families can contribute to important research that might lead to new ways to help young people with sleep problems.

Key takeaways

This study is for children aged 2-17 with insomnia.
It tests a new medicine (tasimelteon) against a dummy medicine (placebo).
Neither you nor the doctors will know who gets which treatment.
The aim is to check if tasimelteon is safe and helps with sleep.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, children and teenagers must be between 2 and 17 years old and have a clear diagnosis of insomnia. This means a doctor has confirmed they have ongoing sleep problems that aren't caused by another medication they are currently taking. It's really important that the sleep issues are due to insomnia itself, not a side effect of another treatment.

We also need the child or their parent/guardian to understand what the study involves and agree to take part. For younger children, their guardian will give permission, and older children will also be asked if they agree to participate. Everyone involved needs to be able to take the study medicine by mouth every day as instructed.

There are also some important reasons why someone might not be able to join. For example, if they've had a bad reaction to tasimelteon before, or if there are signs of liver problems. Pregnant or breastfeeding girls cannot take part, and participants should not have positive tests for drugs of abuse. These rules are in place to keep everyone safe and ensure the study results are clear.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your child aged between 2 and 17 years old?
Has a doctor confirmed your child has insomnia (sleep problems)?
Are your child's sleep problems NOT caused by another medicine they are taking?
Is your child able and willing to take liquid medicine orally every day?
Is your child NOT pregnant or breastfeeding (if applicable)?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive either the study medicine (tasimelteon) or a placebo (a dummy medicine) as a liquid to take by mouth once a day. Neither you nor your study doctor will know which one your child is receiving until the study is over. Your child will have regular visits to the study clinic, where they will be assessed for their sleep patterns, overall health, and any side effects. These assessments might include talking about their sleep, health checks, and possibly blood tests or other evaluations. Your child will need to take the study medicine every day for a specific period. There will also be follow-up checks after the main treatment period to ensure their well-being. The exact length of the study for each participant will be explained by the study team, but it will involve regular appointments and taking the medicine daily.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new medicine that could help improve your child's sleep, or contributing to medical research that could help other children with insomnia in the future. However, there are also potential risks, like experiencing side effects from the study medicine, even the placebo, or the inconvenience of study visits. Your child might not experience any direct benefits. It's important to remember that participation is completely voluntary, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their regular medical care.

Locations (35)

Vanda Investigational Site
Verified postcode
Dothan, United States· Recruiting
Vanda Investigational Site
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Phoenix, United States· Recruiting
Vanda Investigational Site
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Irvine, United States· Recruiting
Vanda Investigational Site
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Miami, United States· Recruiting
Vanda Investigational Site
Verified postcode
Miami Lakes, United States· Recruiting
Vanda Investigational Site
Verified postcode
Winter Park, United States· Recruiting
Vanda Investigational Site
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Snellville, United States· Recruiting
Vanda Investigational Site
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Stockbridge, United States· Recruiting
Vanda Investigational Site
Verified postcode
Naperville, United States· Recruiting
Vanda Investigational Site
Verified postcode
Worcester, United States· Recruiting
Vanda Investigational Site
Verified postcode
Great Falls, United States· Recruiting
Vanda Investigational Site
Verified postcode
Lincoln, United States· Active not recruiting

Common questions

What is insomnia?

Insomnia means having trouble falling asleep, staying asleep, or getting enough restful sleep, which can make you feel tired and affect your daily life.

What is a placebo?

A placebo is a dummy medicine that looks like the real medicine but has no active ingredients. It helps researchers see if the actual medicine really works.

Will my child know if they are getting the real medicine?

No, this is a 'double-blind' study, meaning neither you, your child, nor the doctors will know who is getting the real medicine or the placebo until the study ends.

How long will the study last for my child?

The study team will tell you the exact duration for your child, including how often they'll need to visit and how long they'll take the medicine.

Can my child stop participating if they want to?

Yes, absolutely. Your child can leave the study at any time, for any reason, without it affecting their usual medical care.

How to find out more

Vanda Pharmaceuticals, Inc.

vec162@vandapharma.com 202-734-3400 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.