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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: Completed Phase 3 study of Autism and Attention Deficit Hyperactivity Disorder, sponsored by University of Oklahoma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.
Conditions Studied
Interventions
- DRUG Methylphenidate Transdermal System
Study Locations (1)
Oklahoma
- OU Child Study Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2007-09 |
| Est. Completion | 2010-02 |
| Phase | Phase 3 |
What the finished NCT00541346 record still lists
NCT00541346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 183-participant average among 104 other Autism trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00541346's enrollment target sits among peer trials
16 94th of 104 higher than 10 of 104 other Autism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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