Autism Spectrum Disorder, Neurological Disorder, Sleep Disorder, Sleep Disturbance
Conditions
Brief summary
This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.
Interventions
DRUGTasimelteon Oral Capsule, Tasimelteon Liquid Suspension
Once Daily
Sponsors
Vanda Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required). * A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances. * The sleep disturbance must not be a result of another diagnosable disorder or medication. * Male or female between 2 and 65 years of age, inclusive. * Willing and able to comply with study requirements and restrictions.
Exclusion criteria
* Inability to dose daily with tasimelteon or previous intolerance to tasimelteon. * Indication of impaired liver function. * Evidence of increased risk of self-harm. * Pregnant or lactating females. * A positive test for drugs of abuse. * Other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in sleep time over the treatment period, as measured by sleep diary. | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires. | 12 weeks |
| Improvement in objective behavioral parameters such as the participant's overall behavior, as measured by sleep diary in the Patient Global Impression of Severity Behavior Questionnaire (PGI-S Behavior). | 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
United States
Contacts
Primary ContactVanda Pharmaceuticals Inc.
Outcome results
None listed