At a glance
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Phase III Study of Autism Co-Morbid for Attention Deficit Hyperactivity Disorder
In Brief
A Phase 3 clinical trial evaluating Methylphenidate Transdermal System for Autism and Attention Deficit Hyperactivity Disorder. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage