Safety and Efficacy of Methylphenidate in Children With Attention-deficit Hyperactivity Disorder (ADHD)

This study has been completed.

Sponsor:

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00428792

First received: January 29, 2007

Last updated: April 11, 2011

Last verified: April 2011

History of Changes

Results First Received: January 6, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Condition:	Attention Deficit Hyperactivity Disorder
Intervention:	Drug: Methylphenidate 20 mg long-acting capsules

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

Very Light Breakfast (VLB) Then Standard Breakfast (SB)

Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.

Standard Breakfast (SB) Then Very Light Breakfast (VLB)

Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.

Participant Flow: Overall Study

	Very Light Breakfast (VLB) Then Standard Breakfast (SB)	Standard Breakfast (SB) Then Very Light Breakfast (VLB)
STARTED	80	70
COMPLETED	79 ^[1]	66 ^[1]
NOT COMPLETED	1	4
Lack of Efficacy	1	3
Lost to Follow-up	0	1

[1]	Information is not available during which cross-over period patients discontinued.

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
Very Light Breakfast (VLB) Then Standard Breakfast (SB)	Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
Standard Breakfast (SB) Then Very Light Breakfast (VLB)	Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
Total	Total of all reporting groups

Baseline Measures

	Very Light Breakfast (VLB) Then Standard Breakfast (SB)	Standard Breakfast (SB) Then Very Light Breakfast (VLB)	Total
Number of Participants [units: participants]	80	70	150
Age ^[1] [units: years] Mean (Standard Deviation)	9.6 (1.6)	9.7 (1.5)	9.7 (1.6)
Gender ^[1] [units: participants]
Female	25	13	38
Male	55	57	112

[1]	Safety Population

Outcome Measures

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1. Primary:

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Intent-to-Treat (ITT) Population [ Time Frame: Friday of each of the 2 treatment weeks ]

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2. Primary:

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Teacher Rating in the Per Protocol (PP) Population [ Time Frame: Friday of each of the 2 treatment weeks ]

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3. Secondary:

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Attention Deficit Subscale Teacher Rating [ Time Frame: Friday of each of the 2 treatment weeks ]

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4. Secondary:

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Hyperactivity Subscale Teacher Rating [ Time Frame: Friday of each of the 2 treatment weeks ]

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5. Secondary:

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Impulsiveness Subscale Teacher Rating [ Time Frame: Friday of each of the 2 treatment weeks ]

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6. Secondary:

Fremdbeurteilungsbogen für Aufmerksamkeitsdefizit-Hyperaktivitätsstörungen (FBB-AHDS) Parent Rating [ Time Frame: Saturday of each of the 2 treatment weeks ]

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7. Secondary:

10-Minute Math Test – Problems Attempted [ Time Frame: Saturday of each of the 2 treatment weeks ]

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8. Secondary:

10-Minute Math Test – Problems Solved [ Time Frame: Saturday of each of the 2 treatment weeks ]

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9. Secondary:

Clinical Global Impression Severity (CGI-S) Scale Score – Physician Rating of Severity [ Time Frame: Saturday of each of the 2 treatment weeks ]

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10. Secondary:

Clinical Global Impression (CGI-I) Scale Score – Physician Rating of Improvement (Change in State) [ Time Frame: Saturday of each of the 2 treatment weeks ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.

Results Point of Contact:

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

Responsible Party:	External Affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00428792 History of Changes
Other Study ID Numbers:	CRIT124DDE04
Study First Received:	January 29, 2007
Results First Received:	January 6, 2011
Last Updated:	April 11, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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