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

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanda Pharmaceuticals

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.