What side effects are associated with this type of intervention?

Common treatments for sleep disturbances in children with Autism Spectrum Disorder (ASD) include melatonin and melatonin receptor agonists like Tasimelteon. Known side effects of melatonin are generally mild and may include daytime drowsiness, dizziness, and headaches. Long-term use of melatonin in children has been associated with potential impacts on puberty and mental health, although more research is needed. Other treatments for ASD, such as behavioral interventions, typically have fewer side effects but require consistent implementation. Pharmacological treatments for other symptoms of ASD, such as irritability or hyperactivity, may include antipsychotics or stimulants, which can have side effects like weight gain, sleep disturbances, and gastrointestinal issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Autism Spectrum Disorder (ASD), primarily focusing on managing symptoms such as irritability. However, for sleep disturbances in ASD, melatonin and its receptor agonists like Tasimelteon have been explored. Tasimelteon, approved by the FDA in 2020, is a melatonin receptor agonist used to treat non-24-hour sleep-wake disorder and has shown potential in improving sleep quality in individuals with ASD. Other melatonin-based treatments have been studied for their efficacy and safety in managing sleep problems in children with ASD, indicating a growing interest in this therapeutic approach.

What other types of research exist?

Promising novel alternatives to Tasimelteon for Autism Spectrum Disorder patients include Memantine and Rivastigmine Tartrate. Memantine has shown safety and tolerability in clinical trials, although efficacy was not demonstrated. Rivastigmine Tartrate, a cholinesterase inhibitor, has shown potential in improving language, cognition, and global functioning in ASD patients.

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Melatonin Receptor Agonist

Tasimelteon for Autism and Sleep Disorders

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a daily pill called tasimelteon to help children and adults with Autism Spectrum Disorder (ASD) who have trouble sleeping. The medication aims to improve sleep by helping to regulate the body's internal clock.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TasimelteonExperimental Treatment1 Intervention

Drug: Tasimelteon

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Melatonin and its receptor agonists, such as Tasimelteon, are commonly used to treat sleep disturbances in Autism Spectrum Disorder (ASD) by mimicking the action of natural melatonin. These treatments bind to melatonin receptors in the brain, promoting sleep onset and improving sleep quality. This is crucial for ASD patients, as better sleep can help reduce daytime symptoms like irritability, inattention, and hyperactivity, thereby improving overall quality of life.

Melatonin in autism spectrum disorders.Effectiveness of melatonin in the treatment of sleep disturbances in children with Asperger disorder.