Phase III Study of Autism Co-Morbid for Attention Deficit Hyperactivity Disorder
Sponsor study identifier
interventional
16
1 country
1
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Actual (reported)Study Completion
February 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
October 8, 2007
Actual (reported)October 10, 2007
Actual (reported)May 2009
Actual (reported)February 2010
Actual (reported)February 6, 2014
Actual (reported)Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit
This instrument is a parent rating scale used to assess the frequency of ADHD symptoms based on DSM-IV criteria. Raw scores range from 0-54. Higher scores indicate a higher frequency of ADHD symptoms. Raw scores were used in the analyses described below.
Baseline, 8 weeks
Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit
Baseline, 8 weeks
Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit
Baseline, 8 weeks
Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit
Baseline, 8 weeks
Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit
Baseline, 8 weeks
Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit
Baseline, 8 weeks
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
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
OU Child Study Center
Oklahoma City, Oklahoma, 73117, United States
Abanilla PK, Hannahs GA, Wechsler R, Silva RR. The use of psychostimulants in pervasive developmental disorders. Psychiatr Q. 2005 Fall;76(3):271-81. doi: 10.1007/s11126-005-2980-7.
Thomas M Lock, M.D.
OU Child Study Center
Mark L Wolraich, M.D.
OU Child Study Center
16 participants (actual enrollment reported by the registry).
First Submitted
October 8, 2007
First Posted
October 10, 2007
Study Start
September 2007
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2009
Actual (reported)Study Completion
February 2010
Actual (reported)Last Updated
February 6, 2014
Results First Posted
February 6, 2014
Record last verified: 2013-12
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Source: ClinicalTrials.gov.
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