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

This study has been completed.

Study NCT00337285 Information provided by New River Pharmaceuticals

First Received: June 9, 2006 Last Updated: August 19, 2009 History of Changes

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

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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
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 [ up to one year ]

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2. Secondary:

Number of Participants With Improvement on CGI-I [ Up to 1 year ]

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3. Secondary:

Change in PSQI Total Score From Baseline at Up to One Year [ up to 1 year ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	No text entered.
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Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

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

Other Adverse Events

	Vyvanse
Total, other (not including serious) adverse events
# participants affected	306
Gastrointestinal disorders
Dry mouth * # participants affected / at risk	58/349 (16.62%)
General disorders
Irritability * # participants affected / at risk	39/349 (11.17%)
Infections and infestations
Upper respiratory tract infection * # participants affected / at risk	76/349 (21.78%)
Nasopharyngitis * # participants affected / at risk	26/349 (7.45%)
Sinusitis * # participants affected / at risk	23/349 (6.59%)
Investigations
Weight decreased * # participants affected / at risk	21/349 (6.02%)
Metabolism and nutrition disorders
Decreased appetite * # participants affected / at risk	50/349 (14.33%)
Musculoskeletal and connective tissue disorders
Back pain * # participants affected / at risk	19/349 (5.44%)
Muscle spasms * # participants affected / at risk	18/349 (5.16%)
Nervous system disorders
Headache * # participants affected / at risk	60/349 (17.19%)
Psychiatric disorders
Insomnia * # participants affected / at risk	68/349 (19.48%)
Anxiety * # participants affected / at risk	29/349 (8.31%)

*	Indicates events were collected by non-systematic assessment.

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