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

ClinicalTrials.gov ID: NCT00541346

Public ClinicalTrials.gov record NCT00541346. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Phase III Study of Autism Co-Morbid for Attention Deficit Hyperactivity Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00541346
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: University of Oklahoma; Other
Enrollment: 16 participants

Conditions and interventions

Conditions

Interventions

Methylphenidate Transdermal System Drug

Drug

Eligibility (public fields only)

Age range: 6 Years to 11 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 31, 2007
Primary completion: Apr 30, 2009
Completion: Jan 31, 2010
Last update posted: Feb 5, 2014

2007 – 2010

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
OU Child Study Center	Oklahoma City	Oklahoma	73117	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00541346, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 5, 2014 · Synced Sep 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00541346 live on ClinicalTrials.gov.

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