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Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder (BED)

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: NCT01291173
Recruitment Status : Completed
First Posted : February 8, 2011
Results First Posted : December 31, 2012
Last Update Posted : January 12, 2015
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 Binge Eating Disorder
Interventions Drug: lisdexamfetamine dimesylate (SPD489)
Drug: Placebo
Enrollment 271
Recruitment Details  
Pre-assignment Details A site with 11 enrolled subjects was excluded from study. An external investigation was initiated for reasons unrelated to the respective study. Lacking information on the purpose or scope of the investigation, it was deemed prudent to exclude data from subjects enrolled at site from the primary analyses of efficacy and safety.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description Placebo capsule taken once daily for up to 11 weeks SPD489-30mg capsules taken once daily for up to 11 weeks SPD489 50mg capsules taken once-daily for up to 11 weeks SPD489 70mg capsule taken once-daily for up to 11 weeks
Period Title: Overall Study
Started 64 66 65 65
Completed 47 51 52 52
Not Completed 17 15 13 13
Reason Not Completed
Adverse Event             0             3             1             3
Protocol Violation             7             2             2             5
Withdrawal by Subject             6             4             4             2
Lost to Follow-up             4             6             3             2
Unable to meet visit schedule             0             0             1             0
Lack of compliance             0             0             0             1
Subject was unblinded             0             0             1             0
Excluded therapy             0             0             1             0
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg Total
Hide Arm/Group Description Placebo capsule taken once daily for up to 11 weeks SPD489-30mg capsules taken once daily for up to 11 weeks SPD489 50mg capsules taken once-daily for up to 11 weeks SPD489 70mg capsule taken once-daily for up to 11 weeks Total of all reporting groups
Overall Number of Baseline Participants 63 66 65 65 259
Hide Baseline Analysis Population Description
Safety Analysis Set defined as all randomized subjects who had taken at least 1 dose of investigational product and who had at least 1 follow-up safety assessment completed. One subject in the Placebo group did not have a post-baseline safety assessment and was excluded from the safety population (n=259).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 63 participants 66 participants 65 participants 65 participants 259 participants
38.0  (10.30) 38.4  (11.14) 39.6  (9.32) 38.6  (10.01) 38.7  (10.17)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 63 participants 66 participants 65 participants 65 participants 259 participants
18-39 years 35 35 30 34 134
40-55 years 28 31 35 31 125
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 66 participants 65 participants 65 participants 259 participants
Female
49
  77.8%
57
  86.4%
50
  76.9%
55
  84.6%
211
  81.5%
Male
14
  22.2%
9
  13.6%
15
  23.1%
10
  15.4%
48
  18.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 63 participants 66 participants 65 participants 65 participants 259 participants
63 66 65 65 259
1.Primary Outcome
Title Change From Baseline in Log Transformed Binge Days Per Week at Week 11
Hide Description Binge day is defined as a day during which at least 1 binge episode occurs.
Time Frame Baseline and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Least Squares Mean (Standard Error)
Unit of Measure: Log days
-1.23  (0.069) -1.24  (0.067) -1.49  (0.066) -1.57  (0.067)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8825
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.014
Confidence Interval (2-Sided) 95%
-0.203 to 0.175
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0077
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.258
Confidence Interval (2-Sided) 95%
-0.446 to -0.069
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.345
Confidence Interval (2-Sided) 95%
-0.534 to -0.155
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks
Hide Description The number of binge episodes per week as assessed by clinical interview based on subject diary.
Time Frame Baseline and up to 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Mean (Standard Deviation)
Unit of Measure: Binge Episodes
-4.07  (2.718) -4.57  (3.266) -5.10  (3.026) -5.09  (2.586)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4676
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0198
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0031
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title 1-Week Binge Response, Last Observation Carried Forward (LOCF)
Hide Description The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline [ie, a cessation of binge eating behavior]), or a marked response (75 to <100% reduction in binge episodes from baseline), or a moderate response (50 to <75% reduction in binge episodes from baseline), or a negative/minimal response (<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach.
Time Frame Last 7 days on study
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Measure Type: Number
Unit of Measure: Participants
1 week remission 23 28 33 35
Marked response 15 20 24 23
Moderate response 13 8 4 1
Negative/Minimal response 11 10 3 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3341
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0063
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title 4-Week Binge Response
Hide Description Subjects are free from binge episodes for 4 weeks.
Time Frame Last 28 days on study
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 61 63 64 62
Measure Type: Number
Unit of Measure: Participants
13 22 27 31
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0937
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0127
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline
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
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Measure Type: Number
Unit of Measure: Percentage of participants
Normal, not at all ill 0 0 0 0
Borderline mentally ill 0 0 0 1.6
Mildly ill 1.6 0 3.1 1.6
Moderately ill 56.5 54.5 59.4 42.9
Markedly ill 29.0 30.3 29.7 47.6
Severely ill 11.3 12.1 6.3 6.3
Among the most extremely ill 1.6 3.0 1.6 0
6.Secondary Outcome
Title Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks
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 up to 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 65 64 63
Measure Type: Number
Unit of Measure: Percentage of participants
Normal, not at all ill 37.1 55.4 60.9 65.1
Borderline mentally ill 19.4 26.2 23.4 20.6
Mildly ill 12.9 1.5 6.3 11.1
Moderately ill 24.2 13.8 7.8 3.2
Markedly ill 6.5 1.5 1.6 0
Severely ill 0 0 0 0
Among the most extremely ill 0 1.5 0 0
7.Secondary Outcome
Title Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks
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 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.)
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 65 64 63
Measure Type: Number
Unit of Measure: Percentage of participants
64.5 84.6 90.6 93.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0091
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
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 Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11
Hide Description The YBOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme.
Time Frame Baseline and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-12.0  (0.87) -15.0  (0.84) -15.3  (0.83) -17.0  (0.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0142
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.97
Confidence Interval (2-Sided) 95%
-5.34 to -0.60
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.25
Confidence Interval (2-Sided) 95%
-5.62 to -0.88
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
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 Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.93
Confidence Interval (2-Sided) 95%
-7.30 to -2.56
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11
Hide Description MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression.
Time Frame Baseline and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.7  (0.35) -1.9  (0.34) -1.3  (0.33) -1.6  (0.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7538
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.15
Confidence Interval (2-Sided) 95%
-1.11 to 0.80
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3062
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
-0.45 to 1.44
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7697
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-0.81 to 1.09
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11
Hide Description The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0–56, where <17 indicates mild severity, 18–24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety.
Time Frame Baseline and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.5  (0.30) -0.9  (0.29) -1.1  (0.29) -0.6  (0.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2046
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
-0.29 to 1.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3348
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
-0.42 to 1.22
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0505
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.81
Confidence Interval (2-Sided) 95%
-0.00 to 1.63
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Eating Inventory Score at Week 11
Hide Description The Eating Inventory also known as the Three-Factor Eating Questionnaire is a 51-item self-reported questionnaire intended to assess 3 dimensions of eating behavior: cognitive restraint of eating, disinhibition, and hunger. Cognitive restraint of eating consists of 20 items, disinhibition consists of 16 items, and hunger consists of 15 items. Each item scores either 0 or 1 point for a total score of 0-20 for cognitive restraint of eating, 0-16 for disinhibition, and 0-15 for hunger. A higher score is better for cognitive restraint of eating and lower scores are better for disinhibition and hunger.
Time Frame Baseline and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Cognitive restraint of eating 2.5  (0.65) 4.4  (0.62) 3.8  (0.61) 4.3  (0.62)
Disinhibition -3.8  (0.58) -5.6  (0.56) -6.3  (0.55) -7.2  (0.56)
Hunger -3.3  (0.58) -5.3  (0.56) -6.0  (0.55) -7.8  (0.56)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments Cognitive Restraint of Eating
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0371
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments Cognitive Restraint of Eating
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1380
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments Cognitive Restraint of Eating
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0459
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments Disinhibition
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0278
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments Disinhibition
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments Disinhibition
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments Hunger
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0149
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments Hunger
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments Hunger
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Binge Eating Scale (BES) Score at Week 11
Hide Description The BES is a 16-item self-reported questionnaire that is designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. The items are summed, with possible scores ranging from 0 to 46. A score of 27 or higher indicates severe binge-eating problems, and a score of 17 or lower designates no binge-eating problems.
Time Frame Baseline and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-12.2  (1.28) -16.1  (1.25) -17.6  (1.24) -20.6  (1.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.9
Confidence Interval (2-Sided) 95%
-7.44 to -0.38
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.4
Confidence Interval (2-Sided) 95%
-8.95 to -1.94
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
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 Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -8.5
Confidence Interval (2-Sided) 95%
-11.99 to -4.92
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Barratt Impulsiveness Scale (BIS-11) Total Score at Week 11
Hide Description The BIS-11 is a self-reported 30-item questionnaire that measures impulsiveness using a 4-point Likert scale (rarely/never = 1, occasionally = 2, often = 3, almost always/always = 4). A Total Impulsivity score is calculated by summing the scores for each item. Possible scores range from 30 – 120. Higher scores indicate increased impulsiveness.
Time Frame Baseline and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.1  (1.09) -5.8  (1.05) -5.2  (1.05) -6.9  (1.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0824
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.65
Confidence Interval (2-Sided) 95%
-5.64 to 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1725
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.07
Confidence Interval (2-Sided) 95%
-5.05 to 0.91
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0148
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.71
Confidence Interval (2-Sided) 95%
-6.69 to -0.73
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline in Short Form-12 Health Survey (SF-12) Score at Week 11
Hide Description The SF-12 is a 12-item self-report questionnaire that is a subset of the SF-36 Health Survey. The survey captures physical and mental health. There are 8 subscales. Four of the subscales has one-item each; the other 4 have two-items each. For each subscale, a mean value was first computed and transformed to a position on a scale ranging from 0-100 (Z-transformation). The aggregate total scores are then transformed into a mean value ranging from 0 (lowest level of health) to 100 (highest level of health).
Time Frame Baseline and week 11
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment.
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description:
Placebo capsule taken once daily for up to 11 weeks
SPD489-30mg capsules taken once daily for up to 11 weeks
SPD489 50mg capsules taken once-daily for up to 11 weeks
SPD489 70mg capsule taken once-daily for up to 11 weeks
Overall Number of Participants Analyzed 62 66 64 63
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Aggregate Physical Score 1.3  (0.78) 2.6  (0.75) 2.4  (0.74) 3.9  (0.75)
Aggregate Mental Score 4.9  (1.03) 5.0  (1.00) 5.5  (0.99) 4.9  (1.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments Aggregate Physical Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2504
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
-0.89 to 3.38
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments Aggregate Physical Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3090
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
-1.02 to 3.21
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments Aggregate Physical Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0216
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.50
Confidence Interval (2-Sided) 95%
0.37 to 4.64
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 30 mg
Comments Aggregate Mental Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9587
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-2.75 to 2.90
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 50 mg
Comments Aggregate Mental Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6530
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
-2.17 to 3.45
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Lisdexamfetamine Dimesylate (SPD489) 70 mg
Comments Aggregate Mental Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9814
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-2.79 to 2.86
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Hide Arm/Group Description Placebo capsule taken once daily for up to 11 weeks SPD489-30mg capsules taken once daily for up to 11 weeks SPD489 50mg capsules taken once-daily for up to 11 weeks SPD489 70mg capsule taken once-daily for up to 11 weeks
All-Cause Mortality
Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/63 (0.00%)   2/66 (3.03%)   0/65 (0.00%)   1/65 (1.54%) 
Gastrointestinal disorders         
Pancreatitis acute  0/63 (0.00%)  1/66 (1.52%)  0/65 (0.00%)  0/65 (0.00%) 
Infections and infestations         
Appendicitis  0/63 (0.00%)  1/66 (1.52%)  0/65 (0.00%)  0/65 (0.00%) 
Injury, poisoning and procedural complications         
Drug toxicity  0/63 (0.00%)  0/66 (0.00%)  0/65 (0.00%)  1/65 (1.54%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Placebo Lisdexamfetamine Dimesylate (SPD489) 30 mg Lisdexamfetamine Dimesylate (SPD489) 50 mg Lisdexamfetamine Dimesylate (SPD489) 70 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/63 (58.73%)   57/66 (86.36%)   56/65 (86.15%)   53/65 (81.54%) 
Cardiac disorders         
Palpitations  0/63 (0.00%)  4/66 (6.06%)  2/65 (3.08%)  3/65 (4.62%) 
Tachycardia  0/63 (0.00%)  0/66 (0.00%)  3/65 (4.62%)  2/65 (3.08%) 
Gastrointestinal disorders         
Dry mouth  5/63 (7.94%)  22/66 (33.33%)  22/65 (33.85%)  27/65 (41.54%) 
Nausea  0/63 (0.00%)  5/66 (7.58%)  6/65 (9.23%)  4/65 (6.15%) 
Constipation  1/63 (1.59%)  6/66 (9.09%)  3/65 (4.62%)  5/65 (7.69%) 
Diarrhea  0/63 (0.00%)  4/66 (6.06%)  5/65 (7.69%)  1/65 (1.54%) 
Abdominal pain upper  0/63 (0.00%)  1/66 (1.52%)  1/65 (1.54%)  3/65 (4.62%) 
Abdominal pain  2/63 (3.17%)  0/66 (0.00%)  0/65 (0.00%)  0/65 (0.00%) 
General disorders         
Irritability  4/63 (6.35%)  5/66 (7.58%)  3/65 (4.62%)  3/65 (4.62%) 
Feeling jittery  0/63 (0.00%)  1/66 (1.52%)  3/65 (4.62%)  5/65 (7.69%) 
Fatigue  2/63 (3.17%)  2/66 (3.03%)  3/65 (4.62%)  2/65 (3.08%) 
Energy increased  0/63 (0.00%)  2/66 (3.03%)  2/65 (3.08%)  2/65 (3.08%) 
Infections and infestations         
Nasopharyngitis  2/63 (3.17%)  8/66 (12.12%)  1/65 (1.54%)  3/65 (4.62%) 
Upper respiratory tract infection  4/63 (6.35%)  1/66 (1.52%)  3/65 (4.62%)  5/65 (7.69%) 
Injury, poisoning and procedural complications         
Excoriation  2/63 (3.17%)  0/66 (0.00%)  0/65 (0.00%)  1/65 (1.54%) 
Investigations         
Weight decreased  1/63 (1.59%)  2/66 (3.03%)  4/65 (6.15%)  6/65 (9.23%) 
Metabolism and nutrition disorders         
Decreased appetite  4/63 (6.35%)  17/66 (25.76%)  13/65 (20.00%)  12/65 (18.46%) 
Musculoskeletal and connective tissue disorders         
Neck pain  3/63 (4.76%)  0/66 (0.00%)  1/65 (1.54%)  1/65 (1.54%) 
Arthralgia  3/63 (4.76%)  0/66 (0.00%)  1/65 (1.54%)  0/65 (0.00%) 
Nervous system disorders         
Headache  6/63 (9.52%)  9/66 (13.64%)  9/65 (13.85%)  5/65 (7.69%) 
Dizziness  0/63 (0.00%)  2/66 (3.03%)  1/65 (1.54%)  2/65 (3.08%) 
Psychiatric disorders         
Insomnia  1/63 (1.59%)  7/66 (10.61%)  10/65 (15.38%)  9/65 (13.85%) 
Anxiety  0/63 (0.00%)  4/66 (6.06%)  4/65 (6.15%)  1/65 (1.54%) 
Sleep disorder  0/63 (0.00%)  1/66 (1.52%)  3/65 (4.62%)  4/65 (6.15%) 
Initial insomnia  0/63 (0.00%)  2/66 (3.03%)  2/65 (3.08%)  3/65 (4.62%) 
Skin and subcutaneous tissue disorders         
Hyperhidrosis  2/63 (3.17%)  3/66 (4.55%)  3/65 (4.62%)  2/65 (3.08%) 
Pruritis  2/63 (3.17%)  0/66 (0.00%)  0/65 (0.00%)  0/65 (0.00%) 
External investigation at a site was initiated for reasons unrelated to the study. Lacking information on the investigation, it was deemed prudent to exclude data from subjects enrolled at site (n=11) from the primary analyses of efficacy and safety.
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
Name/Title: Study Physician
Organization: Shire Development LLC
Phone: 1 866-842-5335
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01291173     History of Changes
Other Study ID Numbers: SPD489-208
First Submitted: February 4, 2011
First Posted: February 8, 2011
Results First Submitted: October 26, 2012
Results First Posted: December 31, 2012
Last Update Posted: January 12, 2015