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Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00735371
First Posted: August 14, 2008
Last Update Posted: March 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shire
Results First Submitted: February 1, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
Interventions: Drug: LDX 30 mg
Drug: LDX 50 mg
Drug: LDX 70 mg
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
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 (LDX) 30 mg Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
LDX 50 mg Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
LDX 70 mg Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
Placebo Placebo

Participant Flow:   Overall Study
    Lisdexamfetamine Dimesylate (LDX) 30 mg   LDX 50 mg   LDX 70 mg   Placebo
STARTED   78   79   78   79 
COMPLETED   63   66   67   69 
NOT COMPLETED   15   13   11   10 
Adverse Event                3                3                4                1 
Protocol Violation                2                2                0                3 
Withdrawal by Subject                0                2                2                0 
Lost to Follow-up                1                1                3                1 
Lack of Efficacy                4                2                0                4 
Sponsor Decision                3                1                0                1 
Protocol Violation                0                1                2                0 
Prior Vyvanse Exposure                1                1                0                0 
Exclusion criteria                1                0                0                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.
No text entered.

Reporting Groups
  Description
Lisdexamfetamine Dimesylate (LDX) 30 mg Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
LDX 50 mg Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
LDX 70 mg Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
Placebo Placebo
Total Total of all reporting groups

Baseline Measures
   Lisdexamfetamine Dimesylate (LDX) 30 mg   LDX 50 mg   LDX 70 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 78   79   78   79   314 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      78 100.0%      79 100.0%      78 100.0%      79 100.0%      314 100.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.6  (1.39)   14.7  (1.29)   14.4  (1.30)   14.5  (1.25)   14.6  (1.31) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      19  24.4%      16  20.3%      34  43.6%      25  31.6%      94  29.9% 
Male      59  75.6%      63  79.7%      44  56.4%      54  68.4%      220  70.1% 
Region of Enrollment 
[Units: Participants]
         
United States   78   79   78   79   314 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks   [ Time Frame: Baseline and 1, 2, 3 and 4 weeks ]

2.  Secondary:   Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores   [ Time Frame: 1, 2, 3 and 4 Weeks ]

3.  Secondary:   Youth Quality of Life-Research Version (YQOL-R) Total Score   [ Time Frame: Baseline and 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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:
unchecked 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.
unchecked 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.


Results Point of Contact:  
Name/Title: Timothy Whitaker, MD
Organization: Shire Pharmaceuticals
e-mail: twhitaker@shire.com


Publications of Results:

Responsible Party: Timothy Whitaker, MD/Clinical Research & Development -VP of Global Clinical Medicine, Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00735371     History of Changes
Other Study ID Numbers: SPD489-305
First Submitted: August 12, 2008
First Posted: August 14, 2008
Results First Submitted: February 1, 2010
Results First Posted: February 23, 2010
Last Update Posted: March 20, 2017