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Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17

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: NCT00763971
Recruitment Status : Completed
First Posted : October 1, 2008
Results First Posted : March 22, 2012
Last Update Posted : June 12, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition ADHD
Interventions Drug: Lisdexamfetamine Dimesylate (LDX)
Drug: Methylphenidate Hydrochloride
Drug: Placebo
Enrollment 336
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Hide Arm/Group Description Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg. Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg. Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
Period Title: Overall Study
Started 113 112 111
Completed 80 74 42
Not Completed 33 38 69
Reason Not Completed
Adverse Event             5             2             4
Protocol Violation             3             3             2
Withdrawal by Subject             4             5             5
Lost to Follow-up             0             1             0
Lack of Efficacy             11             22             54
Unable to swallow capsule             2             1             1
Personal reason             3             0             0
Exclusion criteria met             1             0             0
Sponsor decision             1             0             0
Due to holiday season             2             0             1
Randomization error             0             0             1
Medical monitor decision             0             0             1
Moved to another country             0             1             0
Subject wanted dose reduction             0             1             0
Lack of availability             0             1             0
Performed final visit on phone             0             1             0
Participation in 489-326 required             1             0             0
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo Total
Hide Arm/Group Description Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg. Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg. Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks. Total of all reporting groups
Overall Number of Baseline Participants 111 111 110 332
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 111 participants 110 participants 332 participants
10.9  (2.87) 10.9  (2.63) 11.0  (2.82) 10.9  (2.77)
[1]
Measure Description: Safety Population was used for demographics. Safety Population defined as all subjects who took at least 1 dose of investigational product. Four randomized subjects (2 in the LDX group, 1 in the Methylphenidate group, and 1 in the placebo group) did not receive investigational product and were therefore excluded from the Safety Population (n = 332).
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 111 participants 111 participants 110 participants 332 participants
6-12 years 77 80 79 236
13-17 years 34 31 31 96
[1]
Measure Description: Safety Population was used for demographics. Safety Population defined as all subjects who took at least 1 dose of investigational product. Four randomized subjects (2 in the LDX group, 1 in the Methylphenidate group, and 1 in the placebo group) did not receive investigational product and were therefore excluded from the Safety Population (n = 332).
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 111 participants 110 participants 332 participants
Female
24
  21.6%
21
  18.9%
19
  17.3%
64
  19.3%
Male
87
  78.4%
90
  81.1%
91
  82.7%
268
  80.7%
[1]
Measure Description: Safety Population was used for demographics. Safety Population defined as all subjects who took at least 1 dose of investigational product. Four randomized subjects (2 in the LDX group, 1 in the Methylphenidate group, and 1 in the placebo group) did not receive investigational product and were therefore excluded from the Safety Population( n = 332).
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 111 participants 111 participants 110 participants 332 participants
France 10 9 11 30
Hungary 11 10 11 32
Spain 13 14 14 41
Poland 3 4 3 10
Belgium 4 3 4 11
Netherlands 1 0 0 1
Germany 36 36 35 107
United Kingdom 8 10 9 27
Italy 9 9 7 25
Sweden 18 17 17 52
[1]
Measure Description: This includes All Enrolled Subjects. Enrolled Population defined as all subjects who were randomized (n = 336).
1.Primary Outcome
Title Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 7 Weeks
Hide Description The ADHD-RS-IV 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. A decrease in score indicates an improvement in ADHD symptomology.
Time Frame Baseline and up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis set (FAS) defined as all subjects who were randomized and who took at least 1 dose of investigational product.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
Overall Number of Participants Analyzed 98 103 104
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-24.3  (1.16) -18.7  (1.14) -5.7  (1.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in LS means
Estimated Value -18.6
Confidence Interval (2-Sided) 95%
-21.5 to -15.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Methylphenidate Hydrochloride, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in LS means
Estimated Value -13.0
Confidence Interval (2-Sided) 95%
-15.9 to -10.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Hide Description Clinical Global Impression-Improvement (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 Up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
Overall Number of Participants Analyzed 100 104 104
Measure Type: Number
Unit of Measure: percentage of participants
78.0 60.6 14.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 63.6
Confidence Interval (2-Sided) 95%
53.0 to 74.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Methylphenidate Hydrochloride, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in percentages
Estimated Value 46.2
Confidence Interval (2-Sided) 95%
34.6 to 57.7
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Conner's Parent Rating Scale - Revised (CPRS-R) Total Score at up to 7 Weeks
Hide Description The Conner's Parent rating Scale-revised short version (CPRS-R) consists of 27 questions graded on a scale from 0 (not true at all) to 3 (very much true) with a total score ranging from 0 to 81. Higher scores are indicative of increased ADHD. This scale allows parents to respond on the basis of the child's behavior and help assess ADHD and evaluate problem behavior.
Time Frame Baseline and up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
Overall Number of Participants Analyzed 96 99 100
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-24.5  (1.70) -18.4  (1.69) -3.2  (1.69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in LS means
Estimated Value -21.3
Confidence Interval (2-Sided) 95%
-25.5 to -17.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Methylphenidate Hydrochloride, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in LS means
Estimated Value -15.1
Confidence Interval (2-Sided) 95%
-19.3 to -10.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Health Utilities Index-2 (HUI-2) Scores at up to 7 Weeks
Hide Description HUI is used to describe health status and to obtain utility scores by collecting data using one or more questionnaires in formats selected to match the specific study design criteria. Scoring ranges from 0.00 (dead) to 1.00 (perfect health). Higher scores represent better health status.
Time Frame Baseline and up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
Overall Number of Participants Analyzed 98 103 97
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 0.811  (0.1451) 0.822  (0.1377) 0.806  (0.1460)
Up to 7 weeks 0.878  (0.1322) 0.887  (0.1151) 0.843  (0.1431)
5.Secondary Outcome
Title Change From Baseline in the Child Health and Illness Profile, Child Edition: Parent Report Form (CHIP-CE:PRF) Global T-score at up to 7 Weeks
Hide Description The CHIP-CE:PRF evaluates health-related quality of life. It is composed of 5 domains (satisfaction, comfort, resilience, avoidance, and achievement) consisting of a total of 76 items. The global score is an average of the scores for the 5 domains. The majority of items assess frequency of events using a 5-point response format. There is no range for a total score. Raw scale scores are used to generate T-scores. Higher scores indicate better health.
Time Frame Baseline and up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
Overall Number of Participants Analyzed 78 75 80
Least Squares Mean (Standard Error)
Unit of Measure: T-scores
8.6  (1.08) 7.1  (1.10) -0.2  (1.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in LS means
Estimated Value 8.8
Confidence Interval (2-Sided) 95%
6.1 to 11.5
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Methylphenidate Hydrochloride, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in LS means
Estimated Value 7.3
Confidence Interval (2-Sided) 95%
4.6 to 10.0
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Weiss Functional Impairment Rating Scale - Parent Report (WFIRS-P) Global Score at up to 7 Weeks
Hide Description The WFIRS-P is a 50-item scale with each item scored from 0 (never/not at all) to 3 (very often/very much). Mean scores range from 0 to 3. Higher scores indicate greater functional impairment.
Time Frame Baseline and up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
Overall Number of Participants Analyzed 79 83 87
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.3  (0.04) -0.3  (0.04) 0.0  (0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate (LDX), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in LS means
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.4 to -0.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Methylphenidate Hydrochloride, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in LS means
Estimated Value -0.2
Confidence Interval (2-Sided) 95%
-0.3 to -0.1
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Brief Psychiatric Rating Scale for Children (BPRS-C) Total Score at up to 7 Weeks
Hide Description The BPRS-C characterizes psychopathology. A total of 21 items are rated on a scale from 0 (not present) to 6 (extremely severe) with a total score ranging from 0 to 126. A decrease in score indicates a reduction in psychopathology.
Time Frame Baseline and up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population defined as all subjects who took at least 1 dose of investigational product.
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
Overall Number of Participants Analyzed 20 21 22
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-9.15  (11.264) -9.71  (6.936) -2.59  (7.436)
8.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS is a 19-item semi-structured interview designed to capture suicide-related thoughts and behaviors.
Time Frame Up to 7 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg.
Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg.
Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
Overall Number of Participants Analyzed 25 29 27
Measure Type: Number
Unit of Measure: participants
Suicidal ideation 1 0 0
Non-suicidal self injurious behavior 1 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Population defined as all subjects who took at least 1 dose of investigational product.
 
Arm/Group Title Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Hide Arm/Group Description Lisdexamfetamine Dimesylate (LDX, Vyvanse®, SPD489) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 30, 50, or 70 mg. Methylphenidate Hydrochloride (Concerta®, OROS MPH) was administered orally once-daily at approximately 7:00AM for 7 weeks (4-week dose optimization period and a 3-week dose maintenance period) at doses of either 18, 36, or 54 mg. Placebo was administered orally once-daily at approximately 7:00AM for 7 weeks.
All-Cause Mortality
Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/111 (2.70%)      2/111 (1.80%)      3/110 (2.73%)    
Gastrointestinal disorders       
Gastroesophageal reflux disease  1/111 (0.90%)  0/111 (0.00%)  0/110 (0.00%) 
Infections and infestations       
Appendicitis  1/111 (0.90%)  0/111 (0.00%)  0/110 (0.00%) 
Injury, poisoning and procedural complications       
Clavicle fracture  0/111 (0.00%)  0/111 (0.00%)  1/110 (0.91%) 
Overdose  0/111 (0.00%)  1/111 (0.90%)  0/110 (0.00%) 
Nervous system disorders       
Syncope  1/111 (0.90%)  1/111 (0.90%)  0/110 (0.00%) 
Loss of conciousness  0/111 (0.00%)  0/111 (0.00%)  1/110 (0.91%) 
Vascular disorders       
Hematoma  0/111 (0.00%)  0/111 (0.00%)  1/110 (0.91%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Lisdexamfetamine Dimesylate (LDX) Methylphenidate Hydrochloride Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/111 (72.07%)      72/111 (64.86%)      63/110 (57.27%)    
Gastrointestinal disorders       
Abdominal pain  6/111 (5.41%)  6 4/111 (3.60%)  4 6/110 (5.45%)  10
Abdominal upper pain  8/111 (7.21%)  15 9/111 (8.11%)  10 6/110 (5.45%)  9
Diarrhea  5/111 (4.50%)  8 2/111 (1.80%)  2 3/110 (2.73%)  3
Nausea  12/111 (10.81%)  14 8/111 (7.21%)  8 3/110 (2.73%)  4
Vomiting  4/111 (3.60%)  5 4/111 (3.60%)  4 1/110 (0.91%)  1
General disorders       
Fatigue  5/111 (4.50%)  5 1/111 (0.90%)  1 3/110 (2.73%)  3
Irritability  4/111 (3.60%)  6 4/111 (3.60%)  5 0/110 (0.00%)  0
Pyrexia  3/111 (2.70%)  3 5/111 (4.50%)  5 0/110 (0.00%)  0
Infections and infestations       
Gastroenteritis  4/111 (3.60%)  4 3/111 (2.70%)  3 1/110 (0.91%)  1
Influenza  0/111 (0.00%)  0 3/111 (2.70%)  3 0/110 (0.00%)  0
Nasopharyngitis  8/111 (7.21%)  9 14/111 (12.61%)  14 8/110 (7.27%)  9
Upper respiratory tract infection  3/111 (2.70%)  3 1/111 (0.90%)  1 2/110 (1.82%)  2
Injury, poisoning and procedural complications       
Joint sprain  0/111 (0.00%)  0 4/111 (3.60%)  4 1/110 (0.91%)  1
Wrong drug administered  4/111 (3.60%)  4 2/111 (1.80%)  2 1/110 (0.91%)  1
Investigations       
Electrocardiogram QT prolonged  3/111 (2.70%)  7 1/111 (0.90%)  1 1/110 (0.91%)  1
Weight decreased  15/111 (13.51%)  15 5/111 (4.50%)  5 0/110 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  12/111 (10.81%)  13 6/111 (5.41%)  8 2/110 (1.82%)  2
Decreased appetite  28/111 (25.23%)  31 17/111 (15.32%)  21 3/110 (2.73%)  3
Nervous system disorders       
Dizziness  4/111 (3.60%)  4 2/111 (1.80%)  2 1/110 (0.91%)  1
Headache  16/111 (14.41%)  21 22/111 (19.82%)  30 22/110 (20.00%)  27
Migraine  3/111 (2.70%)  4 1/111 (0.90%)  1 0/110 (0.00%)  0
Psychiatric disorders       
Aggression  4/111 (3.60%)  4 3/111 (2.70%)  3 1/110 (0.91%)  1
Initial insomnia  3/111 (2.70%)  3 7/111 (6.31%)  7 1/110 (0.91%)  1
Insomnia  16/111 (14.41%)  16 9/111 (8.11%)  9 0/110 (0.00%)  0
Sleep disorder  6/111 (5.41%)  6 2/111 (1.80%)  2 1/110 (0.91%)  1
Tic  2/111 (1.80%)  2 3/111 (2.70%)  4 2/110 (1.82%)  2
Respiratory, thoracic and mediastinal disorders       
Cough  3/111 (2.70%)  3 8/111 (7.21%)  8 0/110 (0.00%)  0
Skin and subcutaneous tissue disorders       
Erythema  1/111 (0.90%)  1 0/111 (0.00%)  0 3/110 (2.73%)  4
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: Study Physician
Organization: Shire Pharmaceutical
Phone: 1 866-842-5335
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00763971    
Other Study ID Numbers: SPD489-325
2008-000679-90 ( EudraCT Number )
First Submitted: September 30, 2008
First Posted: October 1, 2008
Results First Submitted: February 27, 2012
Results First Posted: March 22, 2012
Last Update Posted: June 12, 2014