Expired Study
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Oklahoma City, Oklahoma 73117


Purpose:

This is an open-label study of the efficacy of Daytrana 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 summary:

The design will be an open-label trial of eight weeks duration with 20 children with Autism co-morbid for ADHD. The subjects will receive 7 days of 10 mg of Daytrana. The children will be seen weekly for assessment for 4 weeks then every two weeks until the eight week period is complete. After each week of treatment, response will be reassessed and the dose will be increased stepwise to 15 mg, 20 mg, 30 mg unless there are excessive side effects, in which case, the dose will be reduced to the previous dose or the patch wear time may be revised.


Criteria:

Inclusion Criteria: - Between 6 and 11 years - Autism Spectrum Disorder - Attention Deficit Hyperactivity Disorder - Stimulant medication-free at study entry - No clinically significant abnormalities that preclude safe participation - Sufficient developmental level (~3 yrs) - Able to keep appointments - Able to communicate effectively - Teacher cooperation Exclusion Criteria: - Received an investigational medication in the previous 30 days - Current medication treatment is effective and well-tolerated - Medical conditions that affect patient safety - MAOIs within one month - Hypertension - Bipolar disorder or psychosis - Anticonvulsants - Psychotropic medication or health food supplement - Tourette Disorder - Seizure disorder - Neurological condition - Structural heart disease


NCT ID:

NCT00541346


Primary Contact:

Principal Investigator
Thomas M Lock, M.D.
OU Child Study Center


Backup Contact:

N/A


Location Contact:

Oklahoma City, Oklahoma 73117
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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