Insomnia Disorder
Conditions
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.
Interventions
Single daily dose, weight-based liquid suspension formulation.
DRUGPlacebo
Placebo comparator.
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sleep latency, as measured by daily sleep diary. | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany, Poland, United Kingdom, United States
Contacts
CONTACTVanda Pharmaceuticals, Inc.
Outcome results
None listed