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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02776215
Recruitment Status : Unknown
Verified January 2017 by Vanda Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : May 18, 2016
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Circadian Rhythm Sleep Disorders Non-24 Hour Sleep-Wake Disorder Autism Spectrum Disorder Smith-Magenis Syndrome Drug: tasimelteon Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018


Arm Intervention/treatment
Experimental: Pharmacokinetic Dosing
Single-dose pharmacokinetics of tasimelteon
Drug: tasimelteon
Melatonin receptor agonist
Other Name: Hetlioz




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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 or males and females with SMS and 3 to <16 years of age with a nighttime sleep complaint and 3 to <18 years of age or males and females with ASD and 3 to <18 years of age with a nighttime sleep complaint;
  2. Weigh at least 16 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:

  1. 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;
  2. The sleep disruption leads to excessive sleepiness or insomnia, or both;
  3. The sleep disturbance causes clinically significant distress or impairment in social, occupational, and other important areas of functioning.

Exclusion Criteria:

  1. 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;
  2. 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;
  3. History of intolerance and/or hypersensitivity to melatonin or melatonin agonists;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02776215


Contacts
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Contact: Vanda Pharmaceuticals 202-734-3400

Locations
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United States, Maryland
Parexel Early Phase Clinical Unit Recruiting
Baltimore, Maryland, United States, 21225
Contact: Amy Roach    667-210-5356    Amy.Roach@parexel.com   
Principal Investigator: Shannon Marriot         
Sponsors and Collaborators
Vanda Pharmaceuticals
Investigators
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Study Director: Vanda Pharmaceuticals Sponsor GmbH
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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02776215    
Other Study ID Numbers: VP-VEC-162-4201
First Posted: May 18, 2016    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Disorders, Circadian Rhythm
Smith-Magenis Syndrome
Disease
Autism Spectrum Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Chronobiology Disorders
Dyssomnias
Occupational Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn