A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.

Sponsor:

Information provided by:

Shire

ClinicalTrials.gov Identifier:

NCT00500149

First received: July 10, 2007

Last updated: March 3, 2015

Last verified: February 2011

History of Changes

Results First Received: December 2, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	ADHD
Interventions:	Drug: Vyvanse (lisdexamfetamine dimesylate) 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
129 subjects were enrolled for dose optimization phase, 12 discontinued, and 117 were randomized to the cross-over phase.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of an open-label dose-optimization phase (4 weeks), followed by a randomized, placebo-controlled, 2-way crossover phase (1 week each).

Reporting Groups

	Description
Vyvanse First	Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the first intervention and matching placebo was given orally once daily for 1 week in the second intervention
Placebo First	Matching placebo was given orally once daily for 1 week in the first intervention and Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the second intervention

Participant Flow for 3 periods

Period 1: Enrolled (Dose-optimization Phase)

	Vyvanse First	Placebo First
STARTED	129	0
COMPLETED	117	0
NOT COMPLETED	12	0
Withdrawal by Subject	3	0
Adverse Event	8	0
Protocol Violation	1	0

Period 2: First Intervention (Cross-over Phase)

	Vyvanse First	Placebo First
STARTED	58	59
COMPLETED	56	57
NOT COMPLETED	2	2
Adverse Event	0	1
Withdrawal by Subject	1	1
Protocol Violation	1	0

Period 3: Second Intervention (Cross-over Phase)

	Vyvanse First	Placebo First
STARTED	56	57
COMPLETED	54	57
NOT COMPLETED	2	0
Lost to Follow-up	2	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
Entire Study Population	No text entered.

Baseline Measures

	Entire Study Population
Overall Participants Analyzed [Units: Participants]	129

Age [Units: Participants]
<=18 years	129
Between 18 and 65 years	0
>=65 years	0

Age [Units: Years] Mean (Standard Deviation)	10.1 (1.5)

Gender [Units: Participants]
Female	31
Male	98

Region of Enrollment [Units: Participants]
United States	129

Outcome Measures

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1. Primary:

Onset of Effect of Vyvanse [ Time Frame: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. ]

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2. Secondary:

Duration of Effect of Vyvanse [ Time Frame: Evaluations were conducted at 1.5, 2.5, 5.0, 7.5, 10.0, 12.0, and 13.0 hours post-dose. ]

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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: If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after SPONSOR confirms there shall be no multicenter Study publication, the INSTITUTION and/or such PRINCIPAL INVESTIGATOR may publish the results from the INSTITUTION site individually.

Results Point of Contact:

Name/Title: Timothy Whitaker, MD
Organization: Shire
e-mail: twhitaker@shire.com

Publications of Results:

Wigal SB, Kollins SH, Childress AC, Squires L; 311 Study Group. A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. Child Adolesc Psychiatry Ment Health. 2009 Jun 9;3(1):17. doi: 10.1186/1753-2000-3-17.

Wigal SB, Kollins SH, Childress AC, Adeyi B. Efficacy and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: sex and age effects and effect size across the day. Child Adolesc Psychiatry Ment Health. 2010 Dec 14;4:32. doi: 10.1186/1753-2000-4-32.

Responsible Party:	Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00500149 History of Changes
Other Study ID Numbers:	SPD489-311
Study First Received:	July 10, 2007
Results First Received:	December 2, 2008
Last Updated:	March 3, 2015

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