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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autism Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methylphenidate Transdermal System

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

Group Type EXPERIMENTAL

Methylphenidate Transdermal System

Intervention Type DRUG

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

Interventions

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Methylphenidate Transdermal System

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

Intervention Type DRUG

Other Intervention Names

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Daytrana, MethylPatch, MTS

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No