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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 pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose
Awards & highlights

Study Summary

This trial will investigate the safety and how the body processes tasimelteon in children and adolescents.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the curver (AUC) of tasimelteon and its metabolites
Half-life of tasimelteon and its metabolites
Brain Diseases, Metabolic
+4 more

Side effects data

From 2012 Phase 3 trial • 20 Patients • NCT01430754
7%
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

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

Find a Location

Who is running the clinical trial?

Vanda PharmaceuticalsLead Sponsor
61 Previous Clinical Trials
19,377 Total Patients Enrolled

Media Library

Tasimelteon (Melatonin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02776215 — Phase 1
Non-24 Sleep Wake Disorder Research Study Groups: Pharmacokinetic Dosing
Non-24 Sleep Wake Disorder Clinical Trial 2023: Tasimelteon Highlights & Side Effects. Trial Name: NCT02776215 — Phase 1
Tasimelteon (Melatonin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02776215 — Phase 1

Frequently Asked Questions

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

Is this clinical trial currently open to new participants?

"According to clinicaltrials.gov, this particular trial is not presently in search of participants. The registration for the study was first published on September 1st, 2016 and last updated February 27th 2017. Although there are no active recruitment efforts as of now, over a thousand other studies are actively seeking candidates to join their trials."

Answered by AI

Could I register for participation in this scientific research?

"This clinical trial is searching for 24 youngsters aged between 3 and 17 with shift-work sleep disorder. All candidates must fulfil the following requirements: exhibiting a persistent or recurrent pattern of circadian disruption; experiencing significant distress owing to disturbed rest/wake cycles; being legally blind (with visual acuity lower than 20/200); weighing at least 16 kg; suffering from either insomnia or excessive drowsiness, etc."

Answered by AI

Is this pioneering research the first of its kind?

"Tasimelteon has been studied since 2016, where it was first sponsored by Vanda Pharmaceuticals. This initial trial involved 24 individuals and led to the Phase 1 drug approval of tasimelteon in the same year. At present, there are two ongoing clinical trials spanning 20 cities across one nation."

Answered by AI

Has the Food and Drug Administration issued its stamp of approval on tasimelteon?

"Tasimelteon's safety rating is 1 due to the limited amount of clinical data that supports its efficacy and risk profile."

Answered by AI

Have previous experiments utilized tasimelteon to assess its effects?

"Currently, 20 different sites are running two separate clinical trials for tasimelteon. One of these is in the late Phase 3 stage. The bulk of research on this medication has taken place within Baltimore, Maryland; however, opportunities to participate exist at additional locations as well."

Answered by AI

Is the age criterion for this trial limited to those below 75 years of age?

"This medical trial is open to participants over the age of 3 and under 17 years old."

Answered by AI

How many individuals are collaborating in this clinical trial?

"Unfortunately, this trial is not currently accepting applicants. It was first introduced on September 1st 2016 and last updated on February 27th 2017. However, if you are seeking alternative studies there are 1172 clinical trials for shift-work sleep disorder and 2 tasimelteon related studies that have open enrollment at the moment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
2016. "Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02776215.
~3 spots leftby Apr 2025
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