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Trial record 1 of 1 for:    NCT00697515
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Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

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.
 
ClinicalTrials.gov Identifier: NCT00697515
Recruitment Status : Completed
First Posted : June 16, 2008
Results First Posted : February 1, 2010
Last Update Posted : December 12, 2011
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition ADHD
Interventions Drug: LDX
Drug: Placebo
Enrollment 142
Recruitment Details  
Pre-assignment Details The study consisted of a 4-week dose optimization phase (30, 50 or 70 mg SPD489 once-daily) and a 2-week crossover phase. Of the 142 subjects enrolled in the dose optimization phase, 15 discontinued prior to randomization.
Arm/Group Title SPD489 First Placebo First
Hide Arm/Group Description Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention. Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
Period Title: Dose Optimization Period
Started 142 0
Completed 127 0
Not Completed 15 0
Reason Not Completed
Adverse Event             4             0
Withdrawal by Subject             5             0
Lost to Follow-up             2             0
sponsor request             2             0
called to active duty             1             0
elevated QTc             1             0
Period Title: First Intervention (Crossover Period)
Started 63 64
Completed 53 52
Not Completed 10 12
Reason Not Completed
Natural disaster             8             9
Adverse Event             0             2
Withdrawal by Subject             2             1
Period Title: Second Intervention (Crossover Period)
Started 53 52
Completed 52 51
Not Completed 1 1
Reason Not Completed
Withdrawal by Subject             1             1
Arm/Group Title Entire Study Population
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 142
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants
<=18 years
0
   0.0%
Between 18 and 65 years
142
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 142 participants
30.5  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants
Female
54
  38.0%
Male
88
  62.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 142 participants
142
1.Primary Outcome
Title Permanent Product Measure of Performance (PERMP) Total Score Over the Treatment Day in the Crossover Phase
Hide Description The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Time Frame 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population defined as all subjects who are randomized and have at least one post-dose primary efficacy assessment.
Arm/Group Title SPD489 Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Placebo is administered once-daily
Overall Number of Participants Analyzed 104 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
312.9  (8.59) 289.5  (8.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title PERMP Total Score by Timepoint in the Crossover Phase
Hide Description The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Time Frame 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title SPD489 Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Placebo is administered once-daily
Overall Number of Participants Analyzed 104 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
2.0 hours post-dose 301.5  (8.78) 285.9  (8.78)
4.0 hours post-dose 314.1  (9.16) 284.7  (9.16)
8.0 hours post-dose 311.4  (9.07) 287.1  (9.07)
10.0 hours post-dose 313.5  (8.82) 288.8  (8.82)
12.0 hours post-dose 318.7  (8.77) 293.1  (8.77)
14.0 hours post-dose 318.6  (9.03) 296.7  (9.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 2.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0017
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 4.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 8.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 10.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 12.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 14.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title PERMP Score for the Number of Math Problems Attempted by Timepoint in the Crossover Phase
Hide Description The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Time Frame 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title SPD489 Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Placebo is administered once-daily
Overall Number of Participants Analyzed 104 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Over the treatment day 158.6  (4.33) 146.6  (4.33)
2.0 hours post-dose 153.1  (4.41) 144.9  (4.41)
4.0 hours post-dose 159.3  (4.60) 144.2  (4.60)
8.0 hours post-dose 157.6  (4.56) 145.3  (4.56)
10.0 hours post-dose 158.6  (4.44) 146.1  (4.44)
12.0 hours post-dose 161.2  (4.43) 148.4  (4.43)
14.0 hours post-dose 161.5  (4.57) 150.4  (4.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments Average over the treatment day
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 2.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0010
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 4.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 8.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 10.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 12.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 14.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title PERMP Score for the Number of Math Problems Answered Correctly by Timepoint in the Crossover Phase
Hide Description The Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
Time Frame 2, 4, 8, 10, 12 and 14 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title SPD489 Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Placebo is administered once-daily
Overall Number of Participants Analyzed 104 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Over the treatment day 154.4  (4.27) 142.9  (4.27)
2.0 hours post-dose 148.4  (4.38) 141.0  (4.38)
4.0 hours post-dose 154.8  (4.56) 140.4  (4.56)
8.0 hours post-dose 153.7  (4.51) 141.7  (4.51)
10.0 hours post-dose 154.8  (4.39) 142.7  (4.39)
12.0 hours post-dose 157.4  (4.36) 144.7  (4.36)
14.0 hours post-dose 157.1  (4.48) 146.3  (4.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments Over the treatment day
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 2.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 4.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 8.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 10.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 12.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments 14.0 hours post-dose
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale With Prompts (ADHD-RS) Total Score at up to 28 Days in the Dose Optimization Phase
Hide Description The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Time Frame Baseline and 7, 14, 21 and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled Efficacy Population (EEP) defined as all subjects who have taken one dose of study medication in the Dose Optimization Phase and had one post-Baseline efficacy assessment.
Arm/Group Title SPD489
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-21.4  (7.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title ADHD-RS With Prompts Total Score in the Crossover Phase
Hide Description The Attention Deficit Hyperactivity Disorder Rating Scale with Prompts (ADHD-RS) consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title SPD489 Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Placebo is administered once-daily
Overall Number of Participants Analyzed 104 104
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
18.1  (0.94) 29.6  (0.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Assessment of Clinical Global Impression-Severity of Illness (CGI-S) in the Dose Optimization Phase
Hide Description CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill)
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
EEP
Arm/Group Title SPD489
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Overall Number of Participants Analyzed 142
Measure Type: Number
Unit of Measure: Participants
Normal, not at all ill 0
Borderline mentally ill 0
Mildly ill 0
Moderately ill 92
Markedly ill 46
Severely ill 4
Among the most extremely ill subjects 0
8.Secondary Outcome
Title Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Dose Optimization Phase
Hide Description CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame 7, 14, 21 and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
EEP
Arm/Group Title SPD489
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Overall Number of Participants Analyzed 132
Measure Type: Number
Unit of Measure: Participants
130
9.Secondary Outcome
Title Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) in the Crossover Phase
Hide Description CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title SPD489 Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Placebo is administered once-daily
Overall Number of Participants Analyzed 103 103
Measure Type: Number
Unit of Measure: Participants
70 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Prescott's Test
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in the Brown Attention Deficit Disorder Scale (BADDS) Total Scores at 26 Days in the Dose Optimization Phase
Hide Description The BADDS assessment consists of 40 items rated on a scale from 0 (never) to 3 (almost daily). The total score ranges from 0 to 120 with increasing scores indicating more severe impairment.
Time Frame Baseline and 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
EEP
Arm/Group Title SPD489
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Overall Number of Participants Analyzed 127
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-34.1  (20.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Level of Satisfaction With Study Treatment on Medication Satisfaction Questionnaire (MSQ) in the Dose Optimization Phase
Hide Description MSQ is a survey rating the subject's level of satisfaction with the study treatment medication.
Time Frame 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
EEP
Arm/Group Title SPD489
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Overall Number of Participants Analyzed 127
Measure Type: Number
Unit of Measure: Participants
Very satisfied 79
Moderately satisfied 44
Not satisfied 2
Don't know 2
12.Secondary Outcome
Title Change From Baseline in Adult ADHD Impact Module (AIM-A) Question 1 Score at 26 Days in the Dose Optimization Phase
Hide Description AIM-A is a quality of life instrument. Question 1 is 'On a scale of 1 to 10, how would you rate the overall quality of life right now?' It is rated on a scale of 1 (worst) to 10 (best).
Time Frame Baseline and 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
EEP
Arm/Group Title SPD489
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Overall Number of Participants Analyzed 127
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.9  (1.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in AIM-A Question 4 Score at 26 Days in the Dose Optimization Phase
Hide Description AIM-A is a quality of life instrument. Question 4 is 'How much do you agree with this statement: Over the past few weeks, I've had more good days than bad days?' This is rated on a scale of 1 (strongly agree) to 5 (strongly disagree).
Time Frame Baseline and 26 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SPD489
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Overall Number of Participants Analyzed 127
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.7  (0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Systolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase
Hide Description [Not Specified]
Time Frame Baseline and 7, 14, 21 and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (SP) defined as all subjects who received at least one dose of study medication.
Arm/Group Title SPD489
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.3  (9.46)
15.Secondary Outcome
Title Change From Baseline in Diastolic Blood Pressure at Up to 28 Days in the Dose Optimization Phase
Hide Description [Not Specified]
Time Frame Baseline and 7, 14, 21 and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
SP
Arm/Group Title SPD489
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: mmHg
-0.2  (6.94)
16.Secondary Outcome
Title Change From Baseline in Pulse Rate at Up to 28 Days in the Dose Optimization Phase
Hide Description [Not Specified]
Time Frame Baseline and 7, 14, 21 and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
SP
Arm/Group Title SPD489
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Overall Number of Participants Analyzed 142
Mean (Standard Deviation)
Unit of Measure: bpm
3.2  (11.55)
17.Secondary Outcome
Title Change From Baseline in Electrocardiogram Results (QTcF Interval) at 7 Days in the Crossover Phase
Hide Description QTcF is the QT interval using Fridericia's correction formula. QT interval is a measure of time between the start of the Q wave and the end of the T wave and is dependent on the heart rate(e.g., the faster the heart rate, the shorter the QT interval). The QT interval has to be corrected in order to aid interpretation.
Time Frame Baseline and 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
SP
Arm/Group Title SPD489 Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg
Placebo is administered once-daily
Overall Number of Participants Analyzed 115 117
Mean (Standard Deviation)
Unit of Measure: msec
4.4  (16.62) 4.8  (15.45)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Population defined as all subjects who received at least one dose of study medication. All 142 subjects received at least one dose of study medication during the dose optimization phase. In the crossover phase, 64 subjects received placebo in the first intervention and 53 in the second intervention for a total of 117 for placebo.
 
Arm/Group Title SPD489 Placebo
Hide Arm/Group Description Lisdexamfetamine Dimesylate (LDX, SPD489) is dosed once-daily at 30, 50 or 70 mg for 1 week during the first intervention and placebo is administered once-daily for 1 week in the second intervention. Placebo is administered once-daily for 1 week in the first intervention and Lisdexamfetamine Dimesylate (LDX, SPD489)is dosed once-daily at 30, 50 or 70 mg for 1 week during the second intervention.
All-Cause Mortality
SPD489 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SPD489 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/142 (0.00%)   0/117 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SPD489 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   113/142 (79.58%)   23/117 (19.66%) 
Gastrointestinal disorders     
Dry mouth  43/142 (30.28%)  0/117 (0.00%) 
Nausea  11/142 (7.75%)  0/117 (0.00%) 
General disorders     
Feeling jittery  8/142 (5.63%)  0/117 (0.00%) 
Irritability  12/142 (8.45%)  0/117 (0.00%) 
Fatigue  0/142 (0.00%)  14/117 (11.97%) 
Infections and infestations     
Upper respiratory tract infection  14/142 (9.86%)  9/117 (7.69%) 
Metabolism and nutrition disorders     
Decreased appetite  52/142 (36.62%)  0/117 (0.00%) 
Nervous system disorders     
Headache  28/142 (19.72%)  0/117 (0.00%) 
Psychiatric disorders     
Anxiety  8/142 (5.63%)  0/117 (0.00%) 
Insomnia  26/142 (18.31%)  0/117 (0.00%) 
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.
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
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Name/Title: Timothy Whitaker, MD
Organization: Shire Pharmaceuticals
EMail: twhitaker@shire.com
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00697515     History of Changes
Other Study ID Numbers: SPD489-316
First Submitted: June 11, 2008
First Posted: June 16, 2008
Results First Submitted: November 20, 2009
Results First Posted: February 1, 2010
Last Update Posted: December 12, 2011