An Open-label Study of NRP104 in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - Study Results

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Conditions:	Attention Deficit Hyperactivity Disorder Attention Deficit Disorders With Hyperactivity Attention Deficit Hyperactivity Disorders
Intervention:	Drug: Vyvanse (lisdexamfetamine dimesylate), NRP104

Participant Flow

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
Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse for up to 1 year.

Reporting Groups

	Description
Vyvanse	Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.

Participant Flow: Overall Study

	Vyvanse
STARTED	349
COMPLETED	191
NOT COMPLETED	158
Withdrawal by Subject	42
Lost to Follow-up	41
Adverse Event	28
Protocol Violation	27
Lack of Efficacy	11
Death	1
Physician Decision	1
Lack of protocol compliance	7

Baseline Characteristics

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Reporting Groups

	Description
Vyvanse	Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.

Baseline Measures

	Vyvanse
Number of Participants [units: participants]	349
Age [units: participants]
<=18 years	0
Between 18 and 65 years	349
>=65 years	0
Age [units: years] Mean ± Standard Deviation	35.8 ± 10.1
Gender [units: participants]
Female	159
Male	190
Region of Enrollment [units: participants]
United States	349

Outcome Measures

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1. Primary:

Change in ADHD-RS-IV Total Score From Baseline at Up to One Year

Measure Type	Primary
Measure Title	Change in ADHD-RS-IV Total Score From Baseline at Up to One Year
Measure Description	Change in the Attention Deficit Hyperactivity Disorder Rating Scale-fourth edition (ADHD-RS-IV) total score from baseline. The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Time Frame	up to one year
Safety Issue	No

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.
Intent-to-treat (ITT). Defined as all subjects who were treated and had both the baseline and at least one post-baseline primary efficacy measurement (i.e., ADHD-RS-IV total score)

Reporting Groups

	Description
Vyvanse	Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.

Measured Values

	Vyvanse
Number of Participants Analyzed [units: participants]	345
Change in ADHD-RS-IV Total Score From Baseline at Up to One Year [units: Units on a scale] Mean ± Standard Deviation	-24.8 ± 11.7

Statistical Analysis 1 for Change in ADHD-RS-IV Total Score From Baseline at Up to One Year

Groups ^[1]	Vyvanse
Method ^[2]	t-test, 2 sided
P Value ^[3]	< 0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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2. Secondary:

Number of Participants With Improvement on CGI-I

Measure Type	Secondary
Measure Title	Number of Participants With Improvement on CGI-I
Measure Description	Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement includes 1 and 2 on the scale.
Time Frame	Up to 1 year
Safety Issue	No

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.
ITT

Reporting Groups

	Description
Vyvanse	Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.

Measured Values

	Vyvanse
Number of Participants Analyzed [units: participants]	345
Number of Participants With Improvement on CGI-I [units: Participants]	290

No statistical analysis provided for Number of Participants With Improvement on CGI-I

3. Secondary:

Change in PSQI Total Score From Baseline at Up to One Year

Measure Type	Secondary
Measure Title	Change in PSQI Total Score From Baseline at Up to One Year
Measure Description	Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire consisting of 18 items which generates seven component scores on a scale from 0 (better sleep) to 3 (worse sleep) resulting in a global score of 0-21, where a higher number reflects worse sleep quality.
Time Frame	up to 1 year
Safety Issue	Yes

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.
Safety population (Defined as all subjects who were enrolled and who received at least one dose of the investigational product.)

Reporting Groups

	Description
Vyvanse	Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.

Measured Values

	Vyvanse
Number of Participants Analyzed [units: participants]	349
Change in PSQI Total Score From Baseline at Up to One Year [units: Units on a scale] Mean ± Standard Deviation	-1.3 ± 2.8

Statistical Analysis 1 for Change in PSQI Total Score From Baseline at Up to One Year

Groups ^[1]	Vyvanse
Method ^[2]	t-test, 2 sided
P Value ^[3]	< 0.0001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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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: 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.

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: Timothy Whitaker
Organization: Shire Pharmaceutical Development, Inc.
e-mail: twhitaker@shire.com

No publications provided

Responsible Party:	Shire Pharmaceutical ( Timothy Whitaker, M.D. )
Study ID Numbers:	NRP104.304
Study First Received:	June 9, 2006
Results First Received:	May 28, 2009
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00337285 History of Changes
Health Authority:	United States: Food and Drug Administration