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.

Study NCT00776009 Information provided by Novartis

First Received on October 16, 2008. Last Updated on June 6, 2011 History of Changes

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
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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
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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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.

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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

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
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300

No publications provided

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