NCT05361707

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

A Study to Evaluate the Efficacy and Safety of Tasimelteon in Treating Sleep Disturbances in Individuals With Autism Spectrum Disorder

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Vanda Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Autism Spectrum Disorder
• Sleep Disorder
• Neurological Disorder
• Sleep Disturbance

Interventions

Type	Name	Description
DRUG	Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension	Once Daily

Timeline

• Start date: 2021-07-28
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-05-05
• Last updated: 2024-03-21

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study