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NCT00541346 · ClinicalTrials.gov registry record · Phase 3

A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms

A Phase 3 study of Autism and Attention Deficit Hyperactivity Disorder, sponsored by University of Oklahoma.

Completed
Registry status
Phase 3
Development phase
16
Enrollment target
1
Study location

NCT00541346 is a Phase 3 study of Autism and Attention Deficit Hyperactivity Disorder that has completed, run by University of Oklahoma. The registered enrollment target is 16 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00541346, a Phase 3 study of Autism and Attention Deficit Hyperactivity Disorder, has completed, sponsored by University of Oklahoma.

COMPLETED
Registry status
Phase 3
Development phase
16 participants
Enrollment target
1
Study location

Study Summary

This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with Autism Spectrum Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total of eight weeks. Changes in core hyperactivity, impulsivity, and inattention symptoms, autism spectrum symptoms and functional outcomes will be assessed. Acceptability of the transdermal route of administration in this population will also be assessed. The researchers hypothesize that Daytrana is a safe and effective medication for children with Autism Spectrum Disorders who have symptoms of inattention, hyperactivity and impulsivity.

Conditions Studied

Autism Attention Deficit Hyperactivity Disorder

Interventions

  • DRUG Methylphenidate Transdermal System

Study Locations (1)

Oklahoma

  • OU Child Study Center - Oklahoma City

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2007-09
Est. Completion 2010-02
Phase Phase 3

Sponsor

University of Oklahoma

358 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00541346

The ClinicalTrials.gov registry entry for NCT00541346 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183-participant average among 104 other Autism trials with a reported enrollment target (91% lower). The listed sponsor is University of Oklahoma, which has 358 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Autism appearing as the primary indexed condition, and to 1 intervention - of which Methylphenidate Transdermal System is the first listed.

NCT00541346 reports 1 study location spanning 1 distinct geographic area - top geographies include Oklahoma.

Frequently Asked Questions

What is clinical trial NCT00541346 about?

NCT00541346 is a clinical study titled "A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms". This is an open-label study of the efficacy of Daytrana (methylphenidate transdermal system) for the treatment of attention and behavioral symptoms in children with Autism Spectrum Disorders. Twenty patients will be enrolled and treated with 10-30 mg of Daytrana for a total of eight weeks. Changes i...

What is the current status of trial NCT00541346?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 16 participants. The study started on 2007-09. Estimated completion is 2010-02.

What conditions does trial NCT00541346 study?

This clinical trial studies the following conditions: Autism, Attention Deficit Hyperactivity Disorder.

What interventions are being tested in trial NCT00541346?

The interventions under investigation include: Methylphenidate Transdermal System (DRUG).

Who is sponsoring clinical trial NCT00541346?

This trial is sponsored by University of Oklahoma, which has 358 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00541346 being conducted?

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

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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.