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

University of Oklahoma (OU)

Status and phase: Completed; Phase 3

Conditions: Attention Deficit Hyperactivity Disorder; Autism

Treatments: Drug: Methylphenidate Transdermal System

Study type: Interventional

Funder types: Other

Identifiers

NCT00541346

SPD485-420-Lock

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 16 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Methylphenidate Transdermal System

Experimental group

Description:

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

Treatment:

Drug: Methylphenidate Transdermal System