Vyvanse Adolescent Open-Label Safety and Efficacy Extension Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00764868
First received: September 29, 2008
Last updated: January 10, 2014
Last verified: January 2014
Results First Received: January 31, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: ADHD
Intervention: Drug: Lisdexamfetamine Dimesylate (LDX)

  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
Subjects had to have satisfied all entry criteria for the antecedent study (SPD489-305, NCT00735371) and completed a minimum of 3 weeks of double-blind treatment and reached Visit 3 of the antecedent study (SPD489-305), without experiencing any clinically significant adverse events that would preclude exposure to LDX.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
269 subjects were enrolled, but 4 were not dosed during the study and thus excluded from the Safety Population.

Reporting Groups
  Description
Lisdexamfetamine Dimesylate (LDX) Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).

Participant Flow:   Overall Study
    Lisdexamfetamine Dimesylate (LDX)  
STARTED     269  
COMPLETED     156  
NOT COMPLETED     113  
Adverse Event                 18  
Withdrawal by Subject                 31  
Non-compliance                 16  
Lost to Follow-up                 25  
Lack of Efficacy                 5  
Subject moved                 7  
Pregnancy                 3  
Prohibited medication                 1  
Out of town                 1  
Misuse and compliance of study drug                 1  
Subject sent to boarding school                 1  
Met an exclusion criteria                 1  
Positive drug screen                 2  
Sponsor requested withdrawal                 1  



  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) Subjects who received either Lisdexamfetamine Dimesylate (LDX) or placebo during antecedent study 489-305 were eligible for 489-306. All subjects were titrated to their optimal dose of LDX (30, 50 or 70 mg per day).

Baseline Measures
    Lisdexamfetamine Dimesylate (LDX)  
Number of Participants  
[units: participants]
  265  
Age [1]
[units: years]
Mean ± Standard Deviation
  14.5  ± 1.30  
Age, Customized  
[units: participants]
 
13 to 14 years     144  
15 to 17 years     121  
Gender  
[units: participants]
 
Female     78  
Male     187  
Region of Enrollment  
[units: participants]
 
United States     265  
[1] Baseline characteristics were calculated from the Safety Population (n = 265) defined as all randomized subjects who received at least 1 dose of investigational product. Baseline and demographic characteristics are calculated from entry into the antecedent study (SPD489-305, NCT00735371).



  Outcome Measures
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1.  Primary:   Change From Baseline (From the Antecedent Study, SPD489-305) in the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) Total Score at up to 52 Weeks   [ Time Frame: Baseline and up to 52 weeks ]

2.  Secondary:   Percent of Participants With Improvement in Clinical Global Impression-Improvement (CGI-I)   [ Time Frame: up to 52 weeks ]

3.  Secondary:   Change From Baseline (From the Antecedent Study, SPD489-305) in the Youth Quality of Life Instrument-Research Version (YQOL-R) Total Score at up to 52 Weeks   [ Time Frame: Baseline and Up to 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


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


No publications provided by Shire

Publications automatically indexed to this study:

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00764868     History of Changes
Other Study ID Numbers: SPD489-306
Study First Received: September 29, 2008
Results First Received: January 31, 2011
Last Updated: January 10, 2014
Health Authority: United States: Food and Drug Administration