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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-21

Study Completion Date

2028-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Insomnia Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tasimelteon

Group Type EXPERIMENTAL

Tasimelteon Oral Suspension

Intervention Type DRUG

Single daily dose, weight-based liquid suspension formulation.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator.

Interventions

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Tasimelteon Oral Suspension

Single daily dose, weight-based liquid suspension formulation.

Intervention Type DRUG

Placebo

Placebo comparator.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No