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NCT Number: NCT06953869

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

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.

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Key information

Conditions

Insomnia Disorder Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Vanda Investigational Site, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Tasimelteon Oral Suspension

Drug

Single daily dose, weight-based liquid suspension formulation.

Placebo

Drug

Placebo comparator.

Primary outcomes

  1. Change in sleep latency, as measured by daily sleep diary.

    Time frame: 12 Weeks

Secondary outcomes

  1. Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary.

    Time frame: 12 Weeks

  2. Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary.

    Time frame: 12 Weeks

  3. Change in daytime functioning, as measured by questionnaire.

    Time frame: 12 Weeks

  4. Change in behavior, as measured by questionnaire.

    Time frame: 12 Weeks

  5. Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy.

    Time frame: 12 Weeks

  6. Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).

    Time frame: 12 Weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Vanda Pharmaceuticals, Inc.

CONTACT

[email protected]

202-734-3400

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
May 1, 2025
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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