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

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ClinicalTrials.gov Identifier: NCT00541346
Recruitment Status : Completed
First Posted : October 10, 2007
Results First Posted : February 6, 2014
Last Update Posted : February 6, 2014
Sponsor:
Collaborator:
Mark L. Wolraich, M.D.
Information provided by (Responsible Party):
University of Oklahoma

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Autism
Attention Deficit Hyperactivity Disorder
Intervention: Drug: Methylphenidate Transdermal System

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
16 enrolled Study Start Date: September, 2007 Study Completion Date:May, 2009 Seen at OU Physician's Child Study Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Methylphenidate Transdermal System 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 when significant side-effects were present.

Participant Flow for 2 periods

Period 1:   Baseline
    Methylphenidate Transdermal System
STARTED   16 
COMPLETED   16 
NOT COMPLETED   0 

Period 2:   Follow-up
    Methylphenidate Transdermal System
STARTED   16 
COMPLETED   15 
NOT COMPLETED   1 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Methylphenidate Transdermal System 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 when significant side-effects were present.

Baseline Measures
   Methylphenidate Transdermal System 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
 
<=18 years   16 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 7.83  (1.23) 
Gender 
[Units: Participants]
 
Female   2 
Male   14 
Region of Enrollment 
[Units: Participants]
 
United States   16 


  Outcome Measures

1.  Primary:   Change in Attention Deficit Hyperactivity Disorder Rating Scale - IV (ADHD-RS-IV) Total Score From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]

2.  Secondary:   Change in Aberrant Behavior Checklist (ABC) Hyperactivity Scores From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]

3.  Secondary:   Change in Aberrant Behavior Checklist (ABC) Irritability Scores From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]

4.  Secondary:   Change in Aberrant Behavior Checklist (ABC) Lethargy Scores From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]

5.  Secondary:   Change in Aberrant Behavior Checklist (ABC) Stereotypy Scores From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]

6.  Secondary:   Change in Aberrant Behavior Checklist (ABC) Inappropriate Speech Scores From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]

7.  Secondary:   Change in Lifetime Participation Scale (LPS) Total Scores From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]

8.  Secondary:   Change in Family III General Scale Summed Score From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]

9.  Secondary:   Change in Pediatric Evaluation Disability Inventory (PEDI) Caregiver Assistance: Self-Care From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]

10.  Secondary:   Change in Pediatric Evaluation Disability Inventory (PEDI) Social Function From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]

11.  Secondary:   Change in Attention Deficit Hyperactivity Disorder Rating Scale IV: Teacher Assessment Total Scores From Baseline to 8-week Follow-up Visit   [ Time Frame: Baseline, 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas M. Lock, M.D.
Organization: University of Oklahoma Health Sciences Center
phone: 405-271-5700 ext 45167
e-mail: Thomas-Lock@ouhsc.edu


Publications:

Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT00541346     History of Changes
Other Study ID Numbers: SPD485-420-Lock
First Submitted: October 8, 2007
First Posted: October 10, 2007
Results First Submitted: November 15, 2010
Results First Posted: February 6, 2014
Last Update Posted: February 6, 2014