Circadian Rhythm Sleep DisordersPhase 1NCT02776215
Study of the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
A Phase 1 study testing tasimelteon in people with Circadian Rhythm Sleep Disorders and Non-24 Hour Sleep-Wake Disorder, run by Vanda Pharmaceuticals at 1 site in United States.
Trial summary
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder, Autism Spectrum Disorder
- What is being tested?
- tasimelteon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2016to 20 Dec 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel Early Phase Clinical Unit
Baltimore, Maryland, 21225
About this study
Official title: Open-label Study to Investigate 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.
Read the detailed description
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.
- Conditions
- Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder, Autism Spectrum Disorder, Smith-Magenis Syndrome
- Being tested
- tasimelteon
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Autism Spectrum Disorder, Smith-Magenis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tasimelteonDrug
Also called Hetlioz
Melatonin receptor agonist
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic Dosing | Experimental | Single-dose pharmacokinetics of tasimelteon Receives: Drug: tasimelteon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curver (AUC) of tasimelteon and its metabolites
Measured: Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose
Maximum concetration (Cmax) of tasimelteon and its metabolites
Measured: Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose
Steady-state concentration (Css) of tasimelteon and its metabolites
Measured: Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose
Half-life of tasimelteon and its metabolites
Measured: Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose
Trough concentration (Ctrough) of tasimelteon and its metabolites
Measured: Pre-dose, 15 minutes post dose, 30 minutes post dose,1 hour post dose, 2 hours post dose, 4 hours post dose
Safety and tolerability of tasimelteon as measured by spontaneous reporting of adverse events (AEs)
Measured: Day 1
Safety and tolerability of tasimelteon as measured by Pediatric Adverse Event Reporting System (PAERS)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start4 Oct 2016
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian Rhythm Sleep DisordersStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vanda Pharmaceuticals, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776215
- Sponsor's protocol ID
- VP-VEC-162-4201
- Status last verified
- Mar 2024
- First submitted
- 16 May 2016
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents
- ClinicalTrials.gov ID
- NCT02776215
- Acronym / sponsor ID
- VP-VEC-162-4201
- Conditions
- Circadian Rhythm Sleep Disorders, Non-24 Hour Sleep-Wake Disorder, Autism Spectrum Disorder, Smith-Magenis Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2016 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label Study to Investigate the Pharmacokinetics and Safety of Tasimelteon in Children and Adolescents.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic Dosing | Experimental | Drug: tasimelteonSingle-dose pharmacokinetics of tasimelteon |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (3 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tasimelteonAlso: HetliozMelatonin receptor agonist | Drug | Pharmacokinetic Dosing |
Primary outcome
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
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
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
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
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
Safety and tolerability of tasimelteon as measured by spontaneous reporting of adverse events (AEs)
Time frame: Day 1
Safety and tolerability of tasimelteon as measured by Pediatric Adverse Event Reporting System (PAERS)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanda Pharmaceuticals study director
Sponsor GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tasimelteon in people with Circadian Rhythm Sleep Disorders and Non-24 Hour Sleep-Wake Disorder, run by Vanda Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.