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

Phase 3

Recruiting

• Conditions: Insomnia Disorder
• Interventions: Drug: Tasimelteon Oral Suspension; Drug: Placebo

• Registration Number: NCT06953869
• Lead Sponsor: Vanda Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-04-01
• Study Start: 2025-04-21
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-05-01
• Last Update Posted: 2025-05-01
• Primary Completion: 2027-11
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 420

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tasimelteon	Tasimelteon Oral Suspension	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in sleep latency, as measured by daily sleep diary.	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary.	12 Weeks
Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary.	12 Weeks
Change in daytime functioning, as measured by questionnaire.	12 Weeks
Change in behavior, as measured by questionnaire.	12 Weeks
Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy.	12 Weeks
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).	12 Weeks

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 San Antonio, Texas, United States