Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
A Multicenter, Double-Blind, Randomized Study to Evaluate the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia
1 other identifier
interventional
420
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2025
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2025
CompletedStudy Start
First participant enrolled
April 21, 2025
CompletedFirst Posted
Study publicly available on registry
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
May 1, 2025
January 1, 2025
2.5 years
April 1, 2025
April 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change in sleep latency, as measured by daily sleep diary.
12 Weeks
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Tasimelteon
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Single daily dose, weight-based liquid suspension formulation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Vanda Investigational Site
Winter Park, Florida, 32789, United States
Vanda Investigational Site
Charlotte, North Carolina, 28277, United States
Vanda Investigational Site
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2025
First Posted
May 1, 2025
Study Start
April 21, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
May 1, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share