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


Study is Available At:


Original ID:

SPD485-420-Lock


NCT ID:

NCT00541346


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

Phase III Study of Autism Co-Morbid for Attention Deficit Hyperactivity Disorder


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

Both


Minimum Age:

6 Years


Maximum Age:

11 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Oklahoma


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

15


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:October 2007
Completion Date:May 2010
Completion Type:Actual
Primary Completion Date:May 2010
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 27, 2010
First Received Date:October 8, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Determine acceptability of the transdermal system to this group of patients and their caretakers
Time Frame:Parent Preferences, 8 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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 - Versi
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:True
Outcome Type:Primary Outcome
Measure: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
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:methylphenidate transdermal system
Description:Daytrana
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Oklahoma
Agency Class:Other
Agency Type:Collaborator
Agency Name:Mark L. Wolraich, M.D.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:16080422

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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