Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Shire

ClinicalTrials.gov Identifier:

NCT01106430

First received: April 14, 2010

Last updated: June 6, 2014

Last verified: February 2014

History of Changes

Results First Received: May 3, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Attention-Deficit/Hyperactivity Disorder
Interventions:	Drug: Lisdexamfetamine Dimesylate Drug: Atomoxetine Hydrochloride

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Lisdexamfetamine Dimesylate	Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Atomoxetine Hydrochloride	Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.

Participant Flow: Overall Study

	Lisdexamfetamine Dimesylate	Atomoxetine Hydrochloride
STARTED	133	134
COMPLETED	100	101
NOT COMPLETED	33	33
Adverse Event	8	10
Lack of Efficacy	2	13
Lost to Follow-up	5	1
Early Termination Requested By Sponsor	1	0
Moved Out Of State	0	1
Refused To Take Medication	0	1
Noncompliance	0	1
Hard Time Swallowing The Pills	1	0
Previous Use Of Marijuana	1	0
Protocol Violation	7	2
Withdrawal by Subject	8	4

Baseline Characteristics

Hide Baseline Characteristics

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 was used for baseline characteristics (n = 262). Defined as all subjects who were randomized and who had taken at least 1 dose of investigational product. Five randomized subjects did not take any investigational product.

Reporting Groups

	Description
Lisdexamfetamine Dimesylate	Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Atomoxetine Hydrochloride	Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
Total	Total of all reporting groups

Baseline Measures

Lisdexamfetamine Dimesylate

Atomoxetine Hydrochloride

Total

Overall Participants Analyzed
[Units: Participants]

128

134

262

Age
[Units: Years]
Mean (Standard Deviation)

10.9 (3.01)

10.4 (2.84)

10.6 (2.93)

Age, Customized
[Units: Participants]

13 - 17 years

6 - 12 years

100

194

Gender
[Units: Participants]

Female

Male

103

197

Region of Enrollment ^[1]
[Units: Participants]

BELGIUM

CANADA

GERMANY

HUNGARY

ITALY

POLAND

SPAIN

SWEDEN

UNITED STATES

138

^[1]	All enrolled subjects defined as all randomized subjects (n = 267).

Outcome Measures

Show All Outcome Measures

1. Primary:

Time to First Response [ Time Frame: 9 weeks ]

Show Outcome Measure 1

2. Secondary:

Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores - Last Observation Carried Forward (LOCF) [ Time Frame: 9 weeks ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-Fourth Edition (ADHD-RS-IV) Total Score at 9 Weeks - LOCF [ Time Frame: Baseline and 9 weeks ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline in the Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at Up to 9 Weeks [ Time Frame: Baseline and up to 9 weeks ]

Show Outcome Measure 4

5. Secondary:

Health Utilities Index-2 (HUI-2) Scores at Up to 9 Weeks [ Time Frame: up to 9 weeks ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at Up to 9 Weeks [ Time Frame: Baseline and up to 9 weeks ]

Show Outcome Measure 6

7. Secondary:

Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 9 weeks ]

Show Outcome Measure 7

8. Secondary:

Udvalg for Kliniske Undersogelser Side Effect Rating Scale - Clinician (UKU-SERS-Clin) With Side Effects Scores >=1 [ Time Frame: 9 weeks ]

Show Outcome Measure 8

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

Limitations and Caveats

Hide 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
No text entered.

More Information

Hide More Information

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: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335

Publications of Results:

Dittmann RW, Cardo E, Nagy P, Anderson CS, Bloomfield R, Caballero B, Higgins N, Hodgkins P, Lyne A, Civil R, Coghill D. Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study. CNS Drugs. 2013 Dec;27(12):1081-92.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nagy P, Häge A, Coghill DR, Caballero B, Adeyi B, Anderson CS, Sikirica V, Cardo E. Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate. Eur Child Adolesc Psychiatry. 2016 Feb;25(2):141-9. doi: 10.1007/s00787-015-0718-0. Epub 2015 May 22.

Dittmann RW, Cardo E, Nagy P, Anderson CS, Adeyi B, Caballero B, Hodgkins P, Civil R, Coghill DR. Treatment response and remission in a double-blind, randomized, head-to-head study of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit hyperactivity disorder. CNS Drugs. 2014 Nov;28(11):1059-69. doi: 10.1007/s40263-014-0188-9.

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01106430 History of Changes
Other Study ID Numbers:	SPD489-317 2009-011745-94 ( EudraCT Number )
Study First Received:	April 14, 2010
Results First Received:	May 3, 2013
Last Updated:	June 6, 2014

To Top