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Recruiting NCT06953869

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

Phase III Interventional Insomnia Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tasimelteon Oral Suspension, Placebo.
Who it may be relevant to
Registry conditions: Insomnia Disorder. Basic parameters: 2 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Germany, Poland, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Tasimelteon Oral Suspension
    Single daily dose, weight-based liquid suspension formulation.
  • Drug Placebo
    Placebo comparator.

Primary outcome measures

  • Change in sleep latency, as measured by daily sleep diary. [Time frame: 12 Weeks]
Secondary outcome measures (6)
  • Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary. [Time frame: 12 Weeks]
  • Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary. [Time frame: 12 Weeks]
  • Change in daytime functioning, as measured by questionnaire. [Time frame: 12 Weeks]
  • Change in behavior, as measured by questionnaire. [Time frame: 12 Weeks]
  • Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy. [Time frame: 12 Weeks]
  • Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs). [Time frame: 12 Weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 21 centers
  • Vanda Investigational Site — Dothan
  • Vanda Investigational Site — Phoenix
  • Vanda Investigational Site — Irvine
  • Vanda Investigational Site — Miami
  • Vanda Investigational Site — Miami Lakes
  • Vanda Investigational Site — Winter Park
  • Vanda Investigational Site — Snellville
  • Vanda Investigational Site — Stockbridge
  • … and 13 more centers
United Kingdom · 7 centers
  • Vanda Investigational Site — Great Yarmouth
  • Vanda Investigational Site — Leicester
  • Vanda Investigational Site — Liverpool
  • Vanda Investigational Site — London
  • Vanda Investigational Site — London
  • Vanda Investigational Site — London
  • Vanda Investigational Site — Sheffield
Poland · 5 centers
  • Vanda Investigational Site — Bydgoszcz
  • Vanda Investigational Site — Gdansk
  • Vanda Investigational Site — Krakow
  • Vanda Investigational Site — Poznan
  • Vanda Investigational Site — Wroclaw
Germany · 2 centers
  • Vanda Investigational Site — Berlin
  • Vanda Investigational Site — Leipzig

Identifiers

NCT: NCT06953869 · VP-VEC-162-3108

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗