Lisdexamfetamine Dimesylate (LDX) Pilot Cognition Study to Evaluate the Utility of a Standardized Battery of Tests in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01010750
First received: November 9, 2009
Last updated: February 6, 2014
Last verified: February 2014
Results First Received: January 7, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Condition: Attention-Deficit Hyperactivity Disorder
Interventions: Drug: Lisdexamfetamine Dimesylate (LDX)
Drug: Immediate Release Mixed Amphetamine Salts (MAS-IR)
Drug: LDX Placebo + MAS-IR Placebo

  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
Each of the 3 treatment regimens was administered daily for 7 days (a total of 21 days of treatment). There was no washout between regimens.

Reporting Groups
  Description
LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo
LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo
MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo
MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo

Participant Flow for 3 periods

Period 1:   First Intervention
    LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo     LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg     Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg     Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg     MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo     MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg  
STARTED     3     4     3     3     2     3  
COMPLETED     3     4     3     3     2     3  
NOT COMPLETED     0     0     0     0     0     0  

Period 2:   Second Intervention
    LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo     LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg     Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg     Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg     MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo     MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg  
STARTED     3     4     3     3     2     3  
COMPLETED     3     3     3     3     2     3  
NOT COMPLETED     0     1     0     0     0     0  
Adverse Event                 0                 1                 0                 0                 0                 0  

Period 3:   Third Intervention
    LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo     LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg     Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg     Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg     MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo     MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg  
STARTED     3     3     3     3     2     3  
COMPLETED     3     3     3     3     2     3  
NOT COMPLETED     0     0     0     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo No text entered.
LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg No text entered.
Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg No text entered.
Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg No text entered.
MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo No text entered.
MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg No text entered.
Total Total of all reporting groups

Baseline Measures
    LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo     LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg     Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg     Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg     MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo     MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg     Total  
Number of Participants  
[units: participants]
  3     4     3     3     2     3     18  
Age  
[units: years]
Mean ± Standard Deviation
  25.0  ± 1.00     24.8  ± 6.70     30.3  ± 6.11     31.3  ± 11.37     53.0  ± 0.00     30.0  ± 11.36     30.8  ± 10.75  
Age, Customized  
[units: participants]
             
<18 years     0     0     0     0     0     0     0  
Between 18 and 55 years     3     4     3     3     2     3     18  
>=56 years     0     0     0     0     0     0     0  
Gender  
[units: participants]
             
Female     0     2     1     1     1     2     7  
Male     3     2     2     2     1     1     11  
Region of Enrollment  
[units: participants]
             
United States     3     4     3     3     2     3     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Power of Attention Score   [ Time Frame: pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7 ]

2.  Secondary:   Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems   [ Time Frame: 2 and 14 hours post-dose on Day 7 ]

3.  Secondary:   CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness   [ Time Frame: 2 and 14 hours post-dose on Day 7 ]

4.  Secondary:   CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability   [ Time Frame: 2 and 14 hours post-dose on Day 7 ]

5.  Secondary:   CAARS-S:S Subscale T-Score: Problems With Self-Concept   [ Time Frame: 2 and 14 hours post-dose on Day 7 ]

6.  Secondary:   CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index   [ Time Frame: 2 and 14 hours post-dose on Day 7 ]


  Serious Adverse Events


  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:
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: Gerald Tremblay, M.D.
Organization: Shire Pharmaceutical
e-mail: gtremblay@shire.com


No publications provided


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01010750     History of Changes
Other Study ID Numbers: SPD489-115
Study First Received: November 9, 2009
Results First Received: January 7, 2011
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration