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Study of the Effect of Individualizing Daytrana Wear-times on Sleep in Children With ADHD (Daytsleep)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Arie Ashkenasi, MD, Cox Health Systems
ClinicalTrials.gov Identifier:
NCT00989950
First received: September 30, 2009
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
Results First Received: March 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Attention Deficit Hyperactivity Disorder
INSOMNIA
Intervention: Drug: Daytrana

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group Sequence 1 Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 2 Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 3 Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
Group Sequence 4 Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun

Participant Flow for 2 periods

 Period 1:   Open Label Dose Optimization
    Group Sequence 1     Group Sequence 2     Group Sequence 3     Group Sequence 4  
STARTED     6     9     4     7  
COMPLETED     6     9     4     7  
NOT COMPLETED     0     0     0     0  

Period 2:   Randomized Phase
    Group Sequence 1     Group Sequence 2     Group Sequence 3     Group Sequence 4  
STARTED     6     9     4     7  
COMPLETED     5     8     4     7  
NOT COMPLETED     1     1     0     0  
Protocol Violation                 1                 0                 0                 0  
Adverse Event                 0                 1                 0                 0  



  Baseline Characteristics
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  Outcome Measures

1.  Primary:   Sleep Latency   [ Time Frame: 9 weeks ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


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
Small sample size, did not permit an examination of more specific differences among patch wear time conditions. Small sample size resulted in weaker randomization to patch wear time sequences that was not completely balanced in baseline covariates.  


Results Point of Contact:  
Name/Title: Arie Ashkenasi, MD
Organization: CoxHealth
phone: 011 972 50 3007477
e-mail: ashkenasi1@gmail.com


Publications of Results:


Responsible Party: Arie Ashkenasi, MD, Cox Health Systems
ClinicalTrials.gov Identifier: NCT00989950     History of Changes
Other Study ID Numbers: cox002, shire IND#54,732
Study First Received: September 30, 2009
Results First Received: March 12, 2012
Last Updated: July 16, 2012
Health Authority: United States: Food and Drug Administration