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Taking people in United StatesPhase 3

Tasimelteon compared with placebo for insomnia in children and teenagers

Tests tasimelteon against placebo in children and teenagers with insomnia disorder.

Key facts

Who runs it
Vanda Pharmaceuticals
Where
Cleveland, Columbia, Dothan, Great Falls, Houston, Irvine, Las Vegas, Lincoln, Miami, Miami Lakes, Myrtle Beach, Naperville, Nashville, Phoenix, Plano, San Antonio, Snellville, Stockbridge, Winter Park, and Worcester, United StatesSee the 20 sitesAlso in 3 other countries, 16 sites
Registry title
Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Status
Recruiting
Phase
Phase 3
People taking part
420 people, planned
Started
21 Apr 2025
Expected to end
Jan 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Tasimelteon Oral Suspension
  • Placebo
Record updated
5 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 2 to 17 years with a confirmed diagnosis of insomnia disorder. They get tasimelteon or a placebo (dummy medicine) once a day by mouth.

Age
2 to 17 years
Sex
All sexes
Disease stage
Confirmed clinical diagnosis of insomnia disorder. The sleep problem must not be caused by another medicine.
Earlier treatment
People who did not tolerate tasimelteon before cannot join.

Main reasons for not taking part

  • Not able to take tasimelteon every day, or did not tolerate it before
  • Signs of poor liver function
  • Pregnant or breastfeeding
  • A positive test for drugs of abuse

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required)
  • Confirmed clinical diagnosis of insomnia disorder
  • Males and Females between 2 and 17 years, inclusive
  • The sleep disturbance must not be a result of another medication

Who cannot take part

  • Inability to dose daily with tasimelteon or previous intolerance to tasimelteon
  • A positive test for drugs of abuse
  • Indication of impaired liver function
  • Pregnant or lactating females

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 2 and 17 years old?

Where in United States

Also in 3 other countries, 16 sites

  • Cleveland, OhioHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Columbia, South CarolinaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Dothan, AlabamaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Great Falls, MontanaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Houston, TexasHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Irvine, CaliforniaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Las Vegas, NevadaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Lincoln, NebraskaHospital not named in the registryContact: Vanda Pharmaceuticals, Inc.No longer taking part
  • Miami, FloridaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Miami Lakes, FloridaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Myrtle Beach, South CarolinaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Naperville, IllinoisHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Nashville, TennesseeHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Phoenix, ArizonaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Plano, TexasHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • San Antonio, TexasHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Snellville, GeorgiaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Stockbridge, GeorgiaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Winter Park, FloridaHospital not named in the registryContact: Vanda PharmaceuticalsTaking people
  • Worcester, MassachusettsHospital not named in the registryContact: Vanda PharmaceuticalsTaking people

About the trial

What the trial wants to find out

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

The 2 groups in the trial

  • TasimelteonTreatment being tested

    Treatment: Tasimelteon Oral Suspension

  • PlaceboPlacebo, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
Plain-language title
Tasimelteon compared with placebo for insomnia in children and teenagersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06953869, who can take part
Record updated
5 June 2026