Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD

This study has been completed.

Sponsor:

Information provided by:

Shire

ClinicalTrials.gov Identifier:

NCT00500071

First received: July 10, 2007

Last updated: January 14, 2011

Last verified: January 2011

History of Changes

Results First Received: May 26, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Attention Deficit Hyperactivity Disorder
Intervention:	Drug: Vyvanse (lisdexamfetamine dimesylate)

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
The study had three phases; 1)screening and wash-out; 2) dose-optimization (5 weeks) and maintenance (2 weeks); 3) 30-day safety follow-up. Dosing ranged from 20-70 mg once daily of Vyvanse.

Reporting Groups

	Description
Vyvanse	Lisdexamfetamine dimesylate (LDX)

Participant Flow for 3 periods

Period 1: Screening and Washout Phase

	Vyvanse
STARTED	318
COMPLETED	317
NOT COMPLETED	1
Protocol Violation	1

Period 2: Dose-optimization and Maintenance Phase

	Vyvanse
STARTED	317 ^[1]
COMPLETED	295
NOT COMPLETED	22
Adverse Event	13
Protocol Violation	2
Lack of Efficacy	2
Withdrawal by Subject	1
Lack of protocol compliance	4

^[1]	Safety population (i.e., received at least one dose of study medication)

Period 3: 30-day Safety Follow-up

	Vyvanse
STARTED	295
COMPLETED	278
NOT COMPLETED	17
Lost to Follow-up	17

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
Vyvanse	Lisdexamfetamine dimesylate (LDX)

Baseline Measures

	Vyvanse
Overall Participants Analyzed [Units: Participants]	318

Age [Units: Participants]
<=18 years	318
Between 18 and 65 years	0
>=65 years	0

Age [Units: Years] Mean (Standard Deviation)	9.1 (1.9)

Gender [Units: Participants]
Female	93
Male	225

Region of Enrollment [Units: Participants]
United States	318

Outcome Measures

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1. Primary:

Change From Baseline in Total Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Score at 7 Weeks [ Time Frame: Baseline and 7 weeks ]

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2. Secondary:

Weekly Change From Baseline in Total ADHD-RS-IV Score [ Time Frame: Baseline and 1, 2, 3, 4, 5, 6, and 7 weeks ]

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3. Secondary:

Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 7 weeks ]

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4. Secondary:

Number of Participants With Improvement onParent Global Assessment (PGA) [ Time Frame: 7 weeks ]

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5. Secondary:

Change From Baseline in Expression and Emotional Scale for Children (EESC) Scores at 7 Weeks [ Time Frame: Baseline and 7 weeks ]

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6. Secondary:

Changes From Baseline in Behavior Rating Inventory of Executive Function (BRIEF) Scores at 7 Weeks [ Time Frame: Baseline and 7 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: 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 Pharmaceutical Development Inc
e-mail: twhitaker@shire.com

Publications of Results:

Findling RL, Ginsberg LD, Jain R, Gao J. Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: an open-label, dose-optimization study. J Child Adolesc Psychopharmacol. 2009 Dec;19(6):649-62. doi: 10.1089/cap.2008.0165.

Katic A, Ginsberg L, Jain R, Adeyi B, Dirks B, Babcock T, Scheckner B, Richards C, Lasser R, Turgay A, Findling RL. Clinically relevant changes in emotional expression in children with ADHD treated with lisdexamfetamine dimesylate. J Atten Disord. 2012 Jul;16(5):384-97. doi: 10.1177/1087054710389990. Epub 2010 Dec 20.

Turgay A, Ginsberg L, Sarkis E, Jain R, Adeyi B, Gao J, Dirks B, Babcock T, Scheckner B, Richards C, Lasser R, Findling RL. Executive function deficits in children with attention-deficit/hyperactivity disorder and improvement with lisdexamfetamine dimesylate in an open-label study. J Child Adolesc Psychopharmacol. 2010 Dec;20(6):503-11. doi: 10.1089/cap.2009.0110.

Responsible Party:	Timothy Whitaker, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00500071 History of Changes
Other Study ID Numbers:	SPD489-310
Study First Received:	July 10, 2007
Results First Received:	May 26, 2009
Last Updated:	January 14, 2011

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