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NCT02776215 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Autism Spectrum Disorder and Smith-Magenis Syndrome, sponsored by Vanda Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target
1
Study location

NCT02776215 is a Phase 1 study of Autism Spectrum Disorder and Smith-Magenis Syndrome that has completed, run by Vanda Pharmaceuticals. The registered enrollment target is 24 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02776215, a Phase 1 study of Autism Spectrum Disorder and Smith-Magenis Syndrome, has completed, sponsored by Vanda Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target
1
Study location

Study Summary

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

Interventions

  • DRUG tasimelteon

Study Locations (1)

Maryland

  • Parexel Early Phase Clinical Unit - Baltimore

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2016-10-04
Est. Completion 2017-12-20
Phase Phase 1

Sponsor

Vanda Pharmaceuticals

68 total trials

What the Registry Record Tells You About NCT02776215

The ClinicalTrials.gov registry entry for NCT02776215 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (82% lower). The listed sponsor is Vanda Pharmaceuticals, which has 68 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which tasimelteon is the first listed.

NCT02776215 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT02776215 about?

NCT02776215 is a clinical study titled "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.

What is the current status of trial NCT02776215?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-10-04. Estimated completion is 2017-12-20.

What conditions does trial NCT02776215 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Smith-Magenis Syndrome, Non-24 Hour Sleep-Wake Disorder, Circadian Rhythm Sleep Disorders.

What interventions are being tested in trial NCT02776215?

The interventions under investigation include: tasimelteon (DRUG).

Who is sponsoring clinical trial NCT02776215?

This trial is sponsored by Vanda Pharmaceuticals, which has 68 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02776215 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.