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

April 23, 2025 updated by: Vanda Pharmaceuticals

A Multicenter, Double-Blind, Randomized Study to Evaluate 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Vanda Investigational Site
        • Contact:
          • Vanda Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo comparator.
Experimental: Tasimelteon
Drug: Tasimelteon Oral Suspension
Single daily dose, weight-based liquid suspension formulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in sleep latency, as measured by daily sleep diary.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary.
Time Frame: 12 Weeks
12 Weeks
Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary.
Time Frame: 12 Weeks
12 Weeks
Change in daytime functioning, as measured by questionnaire.
Time Frame: 12 Weeks
12 Weeks
Change in behavior, as measured by questionnaire.
Time Frame: 12 Weeks
12 Weeks
Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy.
Time Frame: 12 Weeks
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
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 21, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 1, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VEC-162-3108

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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