What side effects are associated with this type of intervention?

Tasimelteon, a melatonin receptor agonist used for Non-24 Sleep Wake Disorder, has been associated with several side effects. Common adverse events include headache, diarrhea, dry mouth, increased alanine aminotransferase, somnolence, dizziness, and nightmares or abnormal dreams. These side effects were generally mild, and there were no significant differences in vital signs, ECGs, or endocrine function between treatment groups.

What prior FDA approvals exist?

Tasimelteon, a melatonin receptor agonist, is FDA-approved for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind individuals. It works by targeting the MT1 and MT2 receptors to regulate the sleep-wake cycle. Another related drug is melatonin, which is often used off-label for circadian rhythm disorders, although it is not specifically FDA-approved for Non-24.

What other types of research exist?

Promising, novel alternatives to Tasimelteon for Non-24 Sleep Wake Disorder patients include ghrelin receptor agonists like TZP-101 and TZP-102, which have shown efficacy in related conditions such as diabetic gastroparesis. Additionally, relamorelin, another ghrelin receptor agonist, has demonstrated significant improvements in gastric emptying and symptoms in clinical trials, indicating potential benefits for circadian rhythm disorders. Further research and clinical trials are necessary to confirm their efficacy specifically for N24SWD.

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Melatonin Receptor Agonist

Tasimelteon for Circadian Rhythm Disorders

Q: What is the mechanism of action of this treatment?

Non-24 Sleep Wake Disorder (Non-24) is characterized by a misalignment of the circadian rhythm with the 24-hour day, often seen in blind individuals. The most common treatments include melatonin receptor agonists such as Tasimelteon. These medications work by binding to melatonin receptors in the brain, specifically MT1 and MT2, which play a crucial role in regulating the sleep-wake cycle. By activating these receptors, melatonin receptor agonists help to synchronize the circadian rhythm with the external environment, thereby improving sleep patterns and daytime alertness. This is particularly important for Non-24 patients as it helps to establish a more regular sleep-wake schedule, significantly enhancing their quality of life.

Phase 1

Waitlist Available

Research Sponsored by Vanda Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Non-24 as determined by DSM-5 diagnostic criteria for the Circadian rhythm sleep-wake disorder, Non-24-hour sleep-wake hour type, with specific criteria related to sleep disruption and its impact

Males or females who are legally blind (defined as having a visual acuity of 20/200 or less in the better-seeing eye with best conventional correction (glasses or contact lenses) and/or a visual field of 20 degrees or less in the better-seeing eye), 3 to <18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial tests tasimelteon, a sleep-regulating medication, in children and adolescents who are legally blind or have certain neurodevelopmental disorders and trouble sleeping. It aims to see how well the medication works and if it is safe for them.

Who is the study for?

This trial is for children and adolescents aged 3 to under 18 years with certain conditions like Autism Spectrum Disorder, Smith-Magenis Syndrome, or Non-24 Sleep Wake Disorder. Participants must weigh at least 16 kg and have a confirmed diagnosis of their condition. Legally blind individuals can join too but shouldn't have untreated psychiatric disorders or other sleep disorders that could interfere with the study.

What is being tested?

The study is testing Tasimelteon's effects on kids' bodies (pharmacokinetics) and its safety. It's an open-label trial, meaning everyone knows they're getting Tasimelteon, which may help manage sleep problems associated with their conditions.

What are the potential side effects?

While not explicitly listed in the provided information, side effects of Tasimelteon may include headache, dizziness or tiredness. Since it's being tested in children and adolescents here, close monitoring will be important to catch any unique reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Non-24-hour sleep-wake disorder.

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I am legally blind, aged between 3 and 18.

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I have been diagnosed with SMS based on genetic testing.

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

Side effects data

From 2012 Phase 3 trial • 20 Patients • NCT01430754

Nasopharyngitis

Blood creatine phosphokinase

Alanine aminotransferase

Crystal urine present

Protein urine present

Headache

Constipation

Diarrhoea

Urine abnormality

Arthralgia

Serotonin Syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Total Run-In

Run-In - Not Randomized

Tasimelteon

Placebo

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pharmacokinetic DosingExperimental Treatment1 Intervention

Single-dose pharmacokinetics of tasimelteon

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tasimelteon

FDA approved

0 / 3Eligibility criteria met

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

Non-24 Sleep Wake Disorder (Non-24) is characterized by a misalignment of the circadian rhythm with the 24-hour day, often seen in blind individuals. The most common treatments include melatonin receptor agonists such as Tasimelteon. These medications work by binding to melatonin receptors in the brain, specifically MT1 and MT2, which play a crucial role in regulating the sleep-wake cycle. By activating these receptors, melatonin receptor agonists help to synchronize the circadian rhythm with the external environment, thereby improving sleep patterns and daytime alertness. This is particularly important for Non-24 patients as it helps to establish a more regular sleep-wake schedule, significantly enhancing their quality of life.

A randomized double-blind placebo-controlled trial of the effectiveness of melatonin on neurocognition and sleep in survivors of childhood cancer.Melatonin for the management of sleep problems in children with neurodevelopmental disorders: a systematic review and meta-analysis.Efficacy of melatonin with behavioural sleep-wake scheduling for delayed sleep-wake phase disorder: A double-blind, randomised clinical trial.