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COMPLETED Phase 3

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

NCT00541346 · View on ClinicalTrials.gov ↗

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.

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

306 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Oklahoma, which has 306 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00541346 reports 1 study location spanning 1 distinct geographic area — top geographies include Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00541346?

The interventions under investigation include: Methylphenidate Transdermal System (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00541346?

This trial is sponsored by University of Oklahoma, which has 306 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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