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NCT Number: NCT02776215

Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.

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Key information

Conditions

Circadian Rhythm Sleep Disorders Abnormalities, Multiple Autism Spectrum Disorder Child Development Disorders, Pervasive Chromosome Disorders Chronobiology Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Genetic Diseases, Inborn Mental Disorders Nervous System Diseases Neurodevelopmental Disorders Non-24 Hour Sleep-Wake Disorder Occupational Diseases Sleep Disorders, Circadian Rhythm Sleep Wake Disorders Smith-Magenis Syndrome

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

About this study

This study is an open-label, single dose, non-controlled study to evaluate the PK and safety of tasimelteon in children and adolescents from 3 years to less than 18 years of age who were legally blind and met the diagnostic criteria for CRSWD Non-24 per DSM-V or who were diagnosed with a Neurodevelopmental Disorder (like ASD and SMS) and had a nighttime sleep complaint.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females 3 to <18 years of age 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], males or females 3 to <18 years of age with SMS and with a nighttime sleep complaint and males or females 3 to <18 years of age with ASD and with a nighttime sleep complaint;
  • Weigh at least 10 kg;

3 Diagnosis of SMS determined by a prior positive genetic test result as indicated by parent/guardian; Diagnosis of ASD as indicated by parent/guardian; or a 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:

  • A persistent or recurrent pattern of sleep disruption that is primarily due to an alteration of the circadian system or to a misalignment between the endogenous circadian rhythm and the sleep-wake schedule required by an individual's physical environment or social or professional schedule;
  • The sleep disruption leads to excessive sleepiness or insomnia, or both;
  • The sleep disturbance causes clinically significant distress or impairment in social, occupational, and other important areas of functioning.

Exclusion criteria

  • For blind subjects only: Subjects who have a probable diagnosis of a current sleep disorder other than Non-24-Hour Sleep-Wake Disorder that is the primary cause of the sleep disturbance based on clinical investigator medical judgment;
  • For blind subjects only: History (within the 12 months prior to screening) of psychiatric disorders including ADHD, Neurodisabilities, Major Depressive Disorder, Generalized Anxiety Disorder, Axis II Disorders, delirium or any other psychiatric disorder, that is not being successfully treated or has not been resolved and that in the opinion of the clinical investigator would affect participation in the study or full compliance with study procedures;
  • History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;

Treatment and study plan

tasimelteon

Drug

Melatonin receptor agonist

Other names: Hetlioz

Primary outcomes

  1. Area under the curver (AUC) of tasimelteon and its metabolites

    Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose

  2. Maximum concetration (Cmax) of tasimelteon and its metabolites

    Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose

  3. Steady-state concentration (Css) of tasimelteon and its metabolites

    Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose

  4. Half-life of tasimelteon and its metabolites

    Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose

  5. Trough concentration (Ctrough) of tasimelteon and its metabolites

    Time frame: Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose

  6. Safety and tolerability of tasimelteon as measured by spontaneous reporting of adverse events (AEs)

    Time frame: Day 1

  7. Safety and tolerability of tasimelteon as measured by Pediatric Adverse Event Reporting System (PAERS)

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 18, 2016
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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