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Clinical Trials in Poland / NCT06953869
Recruiting Phase 3

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

NCT06953869 · tracked via the Priya Life Science Poland tracker
Sponsor
Vanda Pharmaceuticals
Phase
Phase 3
Started
2025-04-21
Last updated
2026-06-05

Condition(s) studied

Insomnia Disorder

Investigational drug(s) / intervention(s)

Tasimelteon Oral Suspension →Placebo

Tasimelteon Oral Suspension: Single daily dose, weight-based liquid suspension formulation.

Placebo: Placebo comparator.

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in sleep latency, as measured by daily sleep diary. — 12 Weeks

Trial sites (35)

FacilityCityRegionStatus
Vanda Investigational Site Dothan Alabama Recruiting
Vanda Investigational Site Phoenix Arizona Recruiting
Vanda Investigational Site Irvine California Recruiting
Vanda Investigational Site Miami Florida Recruiting
Vanda Investigational Site Miami Lakes Florida Recruiting
Vanda Investigational Site Winter Park Florida Recruiting
Vanda Investigational Site Snellville Georgia Recruiting
Vanda Investigational Site Stockbridge Georgia Recruiting
Vanda Investigational Site Naperville Illinois Recruiting
Vanda Investigational Site Worcester Massachusetts Recruiting
Vanda Investigational Site Great Falls Montana Recruiting
Vanda Investigational Site Lincoln Nebraska Active Not Recruiting
Vanda Investigational Site Las Vegas Nevada Recruiting
Vanda Investigational Site Cleveland Ohio Recruiting
Vanda Investigational Site Columbia South Carolina Recruiting
Vanda Investigational Site Myrtle Beach South Carolina Recruiting
Vanda Investigational Site Nashville Tennessee Recruiting
Vanda Investigational Site Houston Texas Recruiting
Vanda Investigational Site Plano Texas Recruiting
Vanda Investigational Site San Antonio Texas Recruiting
Vanda Investigational Site San Antonio Texas Recruiting
Vanda Investigational Site Berlin Germany Recruiting
Vanda Investigational Site Leipzig Germany Recruiting
Vanda Investigational Site Bydgoszcz Poland Recruiting
Vanda Investigational Site Gdansk Poland Recruiting
Vanda Investigational Site Krakow Poland Recruiting
Vanda Investigational Site Poznan Poland Recruiting
Vanda Investigational Site Wroclaw Poland Recruiting
Vanda Investigational Site Great Yarmouth United Kingdom Recruiting
Vanda Investigational Site Leicester United Kingdom Recruiting
Vanda Investigational Site Liverpool United Kingdom Recruiting
Vanda Investigational Site London United Kingdom Recruiting
Vanda Investigational Site London United Kingdom Recruiting
Vanda Investigational Site London United Kingdom Recruiting
Vanda Investigational Site Sheffield United Kingdom Recruiting

More Vanda Pharmaceuticals trials in Poland

Evaluation of Efficacy and Safety of Milsaperidone as Adjunctive Therapy in Patients With Major Depressive Disorder Recruiting
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06953869 on ClinicalTrials.gov ↗ ← All trials in Poland