Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting.

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00776009
First received: October 16, 2008
Last updated: June 6, 2011
Last verified: June 2011
Results First Received: December 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention-Deficit/Hyperactivity Disorder (ADHD)
Interventions: Drug: Dex-Methylphenidate hydrochloride Extended Release (Focalin® XR)
Drug: Placebo

  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
No text entered.

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
Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.

Participant Flow for 3 periods

Period 1:   Period 1: First Intervention
    Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo     Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg     Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo     Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg     Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg     Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg  
STARTED     26     28     29     27     28     27  
COMPLETED     26     27     28     27     26     27  
NOT COMPLETED     0     1     1     0     2     0  
Withdrawal by Subject                 0                 0                 1                 0                 1                 0  
Protocol Violation                 0                 1                 0                 0                 1                 0  

Period 2:   Period 2: Second Intervention
    Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo     Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg     Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo     Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg     Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg     Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg  
STARTED     26     27     28     27     26     27  
COMPLETED     25     27     27     27     26     26  
NOT COMPLETED     1     0     1     0     0     1  
Withdrawal by Subject                 0                 0                 0                 0                 0                 1  
Protocol Violation                 1                 0                 1                 0                 0                 0  

Period 3:   Period 3: Third Intervention
    Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo     Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg     Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo     Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg     Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg     Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg  
STARTED     25     27     27     27     26     26  
COMPLETED     24     27     27     27     26     26  
NOT COMPLETED     1     0     0     0     0     0  
Withdrawal by Subject                 1                 0                 0                 0                 0                 0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days.
Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Placebo orally once a day for 7 days .
Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg Period 1: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days followed by Period 2: Placebo orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days.
Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg Period 1: Placebo orally once a day for 7 days followed by Period 2: Dex-Methylphenidate hydrochloride (Focalin XR) 30 mg dose orally once a day for 7 days followed by Period 3: Dex-Methylphenidate hydrochloride (Focalin XR) 20 mg dose orally once a day for 7 days.
Total Total of all reporting groups

Baseline Measures
    Focalin XR 20 mg First, Then Focalin XR 30 mg, Then Placebo     Focalin XR 30 mg First, Then Placebo, Then Focalin XR 20 mg     Focalin XR 30 mg First, Then Focalin XR 20 mg, Then Placebo     Placebo First, Then Focalin XR 20 mg, Then Focalin XR 30 mg     Focalin XR 20 mg First, Then Placebo, Then Focalin XR 30 mg     Placebo First, Then Focalin XR 30 mg, Then Focalin XR 20 mg     Total  
Number of Participants  
[units: participants]
  26     28     29     27     28     27     165  
Age  
[units: Years]
Mean ± Standard Deviation
  9.3  ± 1.7     9.4  ± 1.7     10.0  ± 1.8     9.4  ± 2.0     9.5  ± 1.8     9.6  ± 2.0     9.6  ± 1.8  
Gender  
[units: participants]
             
Female     9     16     10     10     12     14     71  
Male     17     12     19     17     16     13     94  
Region of Enrollment  
[units: participants]
             
United States     26     28     29     27     28     27     165  



  Outcome Measures
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1.  Primary:   Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Combined Attention and Deportment Scores at 10, 11, and 12 Hour (Averaged) Post-dose   [ Time Frame: Pre-dose to 10, 11, and 12 hours post-dose ]

2.  Secondary:   Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Attention Score at 10, 11, and 12 Hour (Averaged) Post-dose   [ Time Frame: Pre-dose to 10, 11, and 12 hours post-dose ]

3.  Secondary:   Change From Pre-dose in the Swanson, Kotkin, Agler, M Flynn, and Pelham (SKAMP) Deportment Score at 10, 11, and 12 Hour (Averaged) Post-dose   [ Time Frame: Pre-dose to 10, 11, and 12 hours post-dose ]

4.  Secondary:   Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Attempted Score at 10, 11, and 12 Hours (Averaged) Post-dose   [ Time Frame: Pre-dose to 10, 11, and 12 hours post-dose ]

5.  Secondary:   Change From Pre-dose in the Permanent Product Measure of Performance of Measurement (PERMP) Math Test-Correctly Answered Score at 10, 11, and 12 Hours (Averaged) Post-dose   [ Time Frame: Pre-dose to 10, 11, and 12 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300


No publications provided by Novartis

Publications automatically indexed to this study:

Responsible Party: Study Director Novartis Pharmaceuticals, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00776009     History of Changes
Other Study ID Numbers: CRIT124EUS21
Study First Received: October 16, 2008
Results First Received: December 13, 2010
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration