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Melatonin Receptor Agonist
Tasimelteon for Circadian Rhythm Disorders
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
All Individual Drugs Already Approved
No Placebo-Only Group
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 belowSelect...
I have been diagnosed with Non-24-hour sleep-wake disorder.
Select...
I am legally blind, aged between 3 and 18.
Select...
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
Treatment Details
Side effects data
From 2012 Phase 3 trial • 20 Patients • NCT014307547%
Nasopharyngitis
5%
Blood creatine phosphokinase
4%
Alanine aminotransferase
4%
Crystal urine present
4%
Protein urine present
4%
Headache
4%
Constipation
4%
Diarrhoea
4%
Urine abnormality
4%
Arthralgia
2%
Serotonin Syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Total Run-In
Run-In - Not Randomized
Tasimelteon
Placebo
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.
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
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.
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.
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Who is running the clinical trial?
Vanda PharmaceuticalsLead Sponsor
63 Previous Clinical Trials
19,252 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Non-24-hour sleep-wake disorder.I am between 3-18 years old with sleep issues and have SMS or ASD.I am legally blind, aged between 3 and 18.You weigh at least 35 pounds.I have been diagnosed with SMS based on genetic testing.A doctor has said you have ASD, and your parent or guardian agrees.You have had bad reactions to melatonin or similar medications in the past.If you are blind, you will not be eligible if your main sleep problem is caused by a different sleep disorder other than Non-24-Hour Sleep-Wake Disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Pharmacokinetic Dosing
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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