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

NCT05361707 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-21

No results posted yet for this study

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

Interventions

DRUG

Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension

Once Daily

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361707 on ClinicalTrials.gov