Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances

Launched by VANDA PHARMACEUTICALS · Apr 29, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called tasimelteon to see if it can help people with Autism Spectrum Disorder (ASD) who have trouble sleeping. The researchers want to find out if taking tasimelteon once a day can improve sleep for both children and adults with ASD. The trial is currently looking for participants aged 2 to 65 years who have been diagnosed with ASD and have experienced sleep problems that are not caused by other conditions or medications.

To join the study, participants or their legal guardians need to provide consent, and they should be willing to follow the study's guidelines. However, some individuals may not be eligible, such as those with serious liver issues, a history of self-harm, or those who are pregnant or breastfeeding. If you or someone you know might be interested in participating, you can expect to take a daily dose of tasimelteon and be monitored by the research team for any effects on sleep and overall health. This trial aims to better understand how this medication can benefit those with ASD experiencing sleep disturbances.

Gender

ALL

Eligibility criteria

• 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.