A Pilot Study of Daytrana TM in Children With Autism Co-Morbid for Attention Deficit Hyperactivity Disorder (ADHD) Symptoms
This study has been completed.
Sponsor:
University of Oklahoma
Collaborator:
Mark L. Wolraich, M.D.
Information provided by:
University of Oklahoma
ClinicalTrials.gov Identifier:
NCT00541346
First received: October 8, 2007
Last updated: September 27, 2010
Last verified: September 2010
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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 3 |
| 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:
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:
| 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 May 19, 2013