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Melatonin Receptor Agonist

Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension for Autism Spectrum Disorder

Phase 3
Recruiting
Research Sponsored by Vanda Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances
Male or female between 2 and 65 years of age, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

This trial will test if tasimelteon can help with sleep problems in people with ASD.

Who is the study for?
This trial is for children and adults aged 2 to 65 with Autism Spectrum Disorder (ASD) who have trouble sleeping. Participants must be able to follow the study's rules and give consent, or have a guardian who can consent for them. They shouldn't have liver problems, drug abuse issues, or other sleep disorders caused by different conditions.Check my eligibility
What is being tested?
The trial is testing how safe and effective tasimelteon, taken as an oral capsule or liquid suspension once daily, is at improving sleep in people with ASD. It's an open-label study which means everyone knows they're getting the actual medication.See study design
What are the potential side effects?
Tasimelteon may cause side effects like headaches, dizziness or daytime drowsiness. Since it affects sleep patterns, some might experience changes in mood or behavior but specific side effects will vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with ASD and have recent trouble sleeping.
Select...
I am between 2 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in sleep time over the treatment period, as measured by sleep diary.
Secondary outcome measures
Assessment of safety and tolerability of daily single dose of tasimelteon, as measured by spontaneous reporting of adverse events (AEs).
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).
Improvement in objective sleep-wake parameters such as severity of condition, as measured by administered questionnaires.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TasimelteonExperimental Treatment1 Intervention
Drug: Tasimelteon

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor
61 Previous Clinical Trials
19,301 Total Patients Enrolled
1 Trials studying Autism Spectrum Disorder
24 Patients Enrolled for Autism Spectrum Disorder

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we currently looking for more participants for this experiment?

"This is an active clinical trial that was first posted on 7/28/2021, as indicated by the website clinicaltrials.gov. The most recent update to the study was on 4/29/2022."

Answered by AI

Does this trial have an upper age limit for participants?

"This trial is open to patients aged 2 to 65. In total, there are 481 clinical trials for children and 844 for adults over the age of 65."

Answered by AI

How many volunteers are helping with this research?

"That is correct, the clinicaltrials.gov website does show that this study is actively recruiting participants. The trial was originally posted on July 28th, 2021 and was edited most recently on April 29th, 2022. The research team hopes to enroll 100 patients from 5 different medical sites."

Answered by AI

Are there specific inclusion criteria for subjects of this research?

"Eligible participants for this clinical trial should have a diagnosis of autism spectrum disorder and be aged 2 to 65. The researchers are looking to enroll 100 patients in total."

Answered by AI

In how many different geographical areas is this trial being conducted?

"At the moment, there are 5 sites conducting this clinical trial. They are situated in San Jose, Boulder and Staten Island as well as 2 other locations. If you wish to enroll in the study, try and choose a site close to your residence to reduce travel time commitments."

Answered by AI

What are the potential side effects of Tasimelteon Oral Capsule and Tasimelteon Liquid Suspension?

"Tasimelteon Oral Capsule, Tasimelteon Liquid Suspension is classified as a Phase 3 trial medication. This means that there is some data supporting efficacy and multiple rounds of data supporting safety. Consequently, our team at Power rates the safety of this drug as a 3 on a scale from 1 to 3."

Answered by AI

Who else is applying?

What state do they live in?
Colorado
Pennsylvania
New York
Other
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Vanda Investigational Site
How many prior treatments have patients received?
1
3+
2

What questions have other patients asked about this trial?

Can these trial be completed remotely? How long do screening visits last, and how often do they occur?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Autism and sleep disorder have affected me for 60 years. I have ADHD and probably Autism as well. More than one person in my family has signs of both. I am the only one who sought diagnosis, but I also have a niece with confirmed Autism.
PatientReceived 1 prior treatment
~32 spots leftby Jul 2025