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

Sponsor:	University of Oklahoma
Collaborator:	Mark L. Wolraich, M.D.
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00541346

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.

Condition	Intervention	Phase
Autism Attention Deficit Hyperactivity Disorder	Drug: methylphenidate transdermal system	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase III Study of Autism Co-Morbid for Attention Deficit Hyperactivity Disorder

Resource links provided by NLM:

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Autism

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

Determine if Daytrana is safe and well-tolerated by children with Autism co-morbid for ADHD [ Time Frame: Adverse effect reporting for 8 weeks; Pittsburgh Side Effect Rating Scale for 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine if Daytrana is safe and well tolerated by children with Autism co-morbid for ADHD [ Time Frame: Adverse event reporting for 8 weeks; Pittsburgh Side Effect Rating Scale for 8 weeks ] [ Designated as safety issue: Yes ]
Determine if Daytrana is effective in both school and home in significantly reducing symptoms of inattention, hyperactivity and impulsivity in children with Autism co-morbid for ADHD [ Time Frame: ADHDRS-IV Rating Scale Parent and Teacher for 8 weeks ] [ Designated as safety issue: No ]
Determine if Daytrana improves behaviors in the mornings and evenings [ Time Frame: Life Participation Scale for ADHD study start and end, 8 weeks and Family Assessment Measure - Version III at study start and end, 8 weeks ] [ Designated as safety issue: No ]
Determine if parents of children with Autism co-morbid for ADHD are satisfied with the effectiveness of Daytrana [ Time Frame: Parent Preference Assessment, 8 weeks ] [ Designated as safety issue: No ]
Determine if there are any differences in the adverse effects profile of children with Autism co-morbid for ADHD compared to the overall profile for Daytrana [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Determine the degree of functional limitation experienced by this group of children with Autism co-morbid for ADHD and whether this impairment is decreased by treatment with Daytrana [ Time Frame: Pediatric Evaluation of Disability Inventory (PEDI), 8 weeks ] [ Designated as safety issue: No ]
Determine acceptability of the transdermal system to this group of patients and their caretakers [ Time Frame: Parent Preferences, 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	15
Study Start Date:	October 2007
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: methylphenidate transdermal system Daytrana

Detailed 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.

Eligibility

Ages Eligible for Study:	6 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00541346

Locations

United States, Oklahoma
OU Child Study Center
Oklahoma City, Oklahoma, United States, 73117

Sponsors and Collaborators

University of Oklahoma

Mark L. Wolraich, M.D.

Investigators

Principal Investigator:	Thomas M Lock, M.D.	OU Child Study Center
Study Director:	Mark L Wolraich, M.D.	OU Child Study Center

More Information

Publications:

Abanilla PK, Hannahs GA, Wechsler R, Silva RR. The use of psychostimulants in pervasive developmental disorders. Psychiatr Q. 2005 Fall;76(3):271-81. Review.

Responsible Party:	Thomas M. Lock, M.D., OU Child Study Center
ClinicalTrials.gov Identifier:	NCT00541346 History of Changes
Other Study ID Numbers:	SPD485-420-Lock
Study First Received:	October 8, 2007
Last Updated:	September 27, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Oklahoma:

Autism
Autism Spectrum Disorders
ADHD

Additional relevant MeSH terms:

Autistic Disorder
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

Methylphenidate
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012