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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
420
Single daily dose, weight-based liquid suspension formulation.
Placebo comparator.
Vanda Investigational Site
Winter Park, Florida, United States
RECRUITINGVanda Investigational Site
Charlotte, North Carolina, United States
RECRUITINGVanda Investigational Site
San Antonio, Texas, United States
RECRUITINGChange in sleep latency, as measured by daily sleep diary.
Time frame: 12 Weeks
Change in nighttime subjective sleep parameters, such as sleep quality, as measured by sleep diary.
Time frame: 12 Weeks
Change in nighttime subjective sleep parameters, such as sleep time, as measured by sleep diary.
Time frame: 12 Weeks
Change in daytime functioning, as measured by questionnaire.
Time frame: 12 Weeks
Change in behavior, as measured by questionnaire.
Time frame: 12 Weeks
Change in nighttime objective sleep parameters such as sleep time, as measured by actigraphy.
Time frame: 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
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