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

Testing if Tasimelteon helps kids with insomnia better than a placebo.

Recruiting
2-17 years
All
Phase 3

This study is looking at how well a medicine called tasimelteon helps children with trouble sleeping, called insomnia. In this study, some kids will get tasimelteon, while others will get a placebo, which is a pill that doesn’t have medicine in it. The study is double-blind, meaning neither the kids nor the doctors know who gets the real medicine and who gets the placebo. It is also randomized, which means participants are randomly chosen to get either the medicine or placebo.

  • This study includes boys and girls aged 2 to 17 years.
  • Participants must be able to take the medicine daily.
  • There are certain health conditions and situations that can disqualify someone, such as liver problems, pregnancy, or drug abuse.

To join, a parent or guardian needs to agree and sign a form. The study checks if tasimelteon is safe and helps kids sleep better. It's important to know that all participants will have regular check-ups to ensure their safety throughout the study.

Study details
    Insomnia Disorder

NCT06953869

Vanda Pharmaceuticals

6 June 2026

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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