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Trial record 20 of 592 for:    binge eating disorder

SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

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: NCT01718509
Recruitment Status : Completed
First Posted : October 31, 2012
Results First Posted : August 21, 2014
Last Update Posted : November 30, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Binge Eating Disorder
Interventions Drug: SPD489 (Lisdexamfetamine dimesylate)
Drug: Placebo
Enrollment 390
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description Administered once-daily, orally, for up to 12 weeks 50 or 70 mg administered orally, once-daily for up to 12 weeks
Period Title: Overall Study
Started 195 195
Completed 147 147
Not Completed 48 48
Reason Not Completed
Lost to Follow-up             18             15
Withdrawal by Subject             7             13
Adverse Event             5             7
Not specified             13             11
Protocol Violation             4             2
Lack of Efficacy             1             0
Arm/Group Title PLACEBO SPD489 Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 185 181 366
Hide Baseline Analysis Population Description
The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 post-baseline safety assessment. 11 subjects from Site 015, 12 subjects had not been treated, and 1 subject had been treated but did not have any safety follow-up assessments were excluded from the Safety Analysis Set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 185 participants 181 participants 366 participants
38.7  (10.01) 37.1  (10.00) 37.9  (10.02)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 185 participants 181 participants 366 participants
< 40 years 90 108 198
>= 40 years 95 73 168
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 185 participants 181 participants 366 participants
Female
153
  82.7%
159
  87.8%
312
  85.2%
Male
32
  17.3%
22
  12.2%
54
  14.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 185 participants 181 participants 366 participants
GERMANY 9 11 20
UNITED STATES 176 170 346
1.Primary Outcome
Title Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12
Hide Description Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.
Time Frame Baseline and Visit 8 Which Spans Weeks 11/12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week).
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 176 174
Least Squares Mean (Standard Error)
Unit of Measure: Binge days per week
-2.26  (0.137) -3.92  (0.135)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
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 Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.66
Confidence Interval (2-Sided) 95%
-2.04 to -1.28
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percent 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 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 176 174
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
42.9
(35.5 to 50.2)
86.2
(81.1 to 91.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
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 Chi-squared
Comments [Not Specified]
3.Secondary Outcome
Title Percent of Participants With a 4-Week Cessation From Binge Eating
Hide Description 4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 176 174
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.1
(8.1 to 18.0)
36.2
(29.1 to 43.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
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 Chi-squared
Comments [Not Specified]
4.Secondary Outcome
Title Percent Change From Baseline in Body Weight (kg) at Week 12
Hide Description [Not Specified]
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 176 174
Least Squares Mean (Standard Error)
Unit of Measure: percentage change
-0.15  (0.353) -5.57  (0.350)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
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 Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -5.41
Confidence Interval (2-Sided) 95%
-6.39 to -4.44
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12
Hide Description The Y-BOCS-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. Reduction in total score indicates improvement.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 176 174
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-7.42  (0.571) -15.36  (0.563)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
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 Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.94
Confidence Interval (2-Sided) 95%
-9.51 to -6.36
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Not all subjects had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 153 156
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
0.062  (0.0453) -0.133  (0.0449)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.196
Confidence Interval (2-Sided) 95%
-0.321 to -0.070
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Not all subjects had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 153 156
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.126  (0.0460) -0.204  (0.0456)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.077
Confidence Interval (2-Sided) 95%
-0.205 to 0.050
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks
Hide Description [Not Specified]
Time Frame Baseline and up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Not all subjects had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 154 156
Least Squares Mean (Standard Error)
Unit of Measure: Percent
-0.02  (0.017) 0.01  (0.017)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.185
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.02 to 0.08
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Binge Eating Response
Hide Description

Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows:

  • 1-week Cessation = 100% reduction in binge episodes during the preceding 7 days
  • Marked Reduction = 99% to 75% reduction during the time since the previous visit
  • Moderate Reduction = 74% to 50% reduction during the time since the previous visit
  • Negative to Minimal Reduction = <50% reduction during the time since the previous visit
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Not all subjects had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 142 145
Measure Type: Number
Unit of Measure: percentage of participants
1-week cessation 23.9 55.9
Marked reduction 13.4 22.8
Moderate reduction 19.7 16.6
Negative to minimal reduction 43.0 4.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity is not adjusted for this secondary efficacy endpoint in this study.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12
Hide Description [Not Specified]
Time Frame Baseline and Visit 8 Which Spans Weeks 11/12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 176 174
Least Squares Mean (Standard Error)
Unit of Measure: Binge episodes per week
-3.31  (0.194) -5.54  (0.193)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity is not adjusted for this secondary efficacy endpoint in this study.
Method Mixed Models Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.23
Confidence Interval (2-Sided) 95%
-2.77 to -1.69
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Eating Inventory Scores at Week 12
Hide Description There are 36 true/false items, 14 items on a 4-point Likert scale (1=eat rarely to 4=always), and 1 item on a 6-point Likert scale (1=eat whatever you want to 6=constantly limiting food intake). Cognitive Restraint score ranges from 0-21. Hunger score ranges from 0-14. Disinhibition score ranges from 0-16. Higher scores denote higher levels of restrained eating, disinhibited eating and predisposition to hunger.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 176 174
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Cognitive Restraint of Eating 2.44  (0.352) 3.71  (0.347)
Disinhibition of Eating -2.01  (0.305) -5.61  (0.300)
Perceived Hunger -1.93  (0.318) -6.14  (0.313)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
Comments Cognitive Restraint of Eating
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments Multiplicity is not adjusted for this secondary efficacy endpoint in this study.
Method Mixed Models Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.29 to 2.24
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
Comments Disinhibition of Eating
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity is not adjusted for this secondary efficacy endpoint in this study.
Method Mixed Models Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.60
Confidence Interval (2-Sided) 95%
-4.44 to -2.76
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
Comments Perceived Hunger
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity is not adjusted for this secondary efficacy endpoint in this study.
Method Mixed Models Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -4.21
Confidence Interval (2-Sided) 95%
-5.09 to -3.33
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in Binge Eating Scale (BES) Score at Week 12
Hide Description The BES is a self-reported questionnaire containing 16 items designed to assess behavioral, affective, and attitudinal components of the subjective experience of binge eating. Each item is assessed based on 1 of 4 responses, with 1 denoting that a subject has greater control over eating behavior and 4 denoting that a subject had less control over eating behavior. A total score (sum of the 16 items) may range from 16-64. A lower score indicates greater control over eating behavior.
Time Frame Baseline and week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 176 174
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.24  (0.781) -17.52  (0.771)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Multiplicity is not adjusted for this secondary efficacy endpoint in this study.
Method Mixed Models Repeated Measures Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -9.28
Confidence Interval (2-Sided) 95%
-11.44 to -7.12
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks
Hide Description The FrSBe is a 46-item self-rating scale designed to measure the neurobehavioral traits associated with the 3 primary regions of the prefrontal cortex. Subjects were asked to indicate the frequency with which they have engaged in certain behaviors using a rating scale from “1” (almost never) to “5” (almost always). Summary scores were calculated and converted to t-score. A decrease from baseline in FrSBe total score represents improvement.
Time Frame Baseline and up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Not all subjects had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 153 158
Least Squares Mean (Standard Error)
Unit of Measure: t-scores
-3.09  (0.655) -4.05  (0.644)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PLACEBO, SPD489
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.298
Comments Multiplicity is not adjusted for this secondary efficacy endpoint in this study.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-2.77 to 0.85
Estimation Comments [Not Specified]
14.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility
Hide Description Quality of life was assessed using the EQ-5D-5L, which is one of the most widely used generic index measures of health-related quality of life. It consists of a 5-item descriptive system that measures 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Not all subjects had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 168 169
Measure Type: Number
Unit of Measure: percentage of participants
No problems in walking about 86.9 91.7
Slight problems in walking about 8.9 7.1
Moderate problems walking about 3.0 0.6
Severe problems walking about 1.2 0.6
Unable to walk about 0 0
15.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Not all subjects had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 168 169
Measure Type: Number
Unit of Measure: percentage of participants
No problems washing or dressing 97.0 97.0
Slight problems washing or dressing 2.4 3.0
Moderate problems washing or dressing 0.6 0
Severe problems washing or dressing 0 0
Unable to wash or dress 0 0
16.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Not all subjects had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 168 169
Measure Type: Number
Unit of Measure: percentage of participants
No problems doing usual activities 82.1 89.9
Slight problems dosin usual activities 14.3 8.3
Moderate problems doing usual activities 3.0 1.2
Severe problems doing usual activities 0.6 0.6
Unable to do usual activities 0 0
17.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Not all subjects had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 168 169
Measure Type: Number
Unit of Measure: percentage of participants
No pain or discomfort 75.6 76.3
Slight pain or discomfort 18.5 20.1
Moderate pain or discomfort 3.0 3.0
Severe pain or discomfort 3.0 0
Extreme pain or discomfort 0 0.6
18.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set. Not all subjects had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 168 169
Measure Type: Number
Unit of Measure: percentage of participants
Not anxious or depressed 69.6 76.3
Slightly anxious or depressed 23.2 20.7
Moderately anxious or depressed 4.8 2.4
Severely anxious or depressed 1.2 0
Extremely anxious or depressed 1.2 0.6
19.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS is a semi-structured interview that captures the occurence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour occurred. The assessment is done by the nature of the responses, not by a numbered scale.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. All subjects from Site 015 were excluded from the Safety Analysis Set.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 183 179
Measure Type: Number
Unit of Measure: participants
Suicidal ideation 0 0
Suicidal behavior 0 0
20.Secondary Outcome
Title Amphetamine Cessation Symptom Assessment (ACSA) Total Score
Hide Description ACSA scale has 16 symptom items rated on a scale from 0 (not at all) to 4 (extremely) with a possible total score range of 0 to 64. Higher scores indicate greater withdrawal symptom severity.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Administered once-daily, orally, for up to 12 weeks
50 or 70 mg administered orally, once-daily for up to 12 weeks
Overall Number of Participants Analyzed 142 135
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.0  (7.69) 4.6  (5.83)
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety Analysis Set defined as all randomized subjects who took at least 1 dose of investigational product and had at least 1 follow-up safety assessment.
 
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description Administered once-daily, orally, for up to 12 weeks 50 or 70 mg administered orally, once-daily for up to 12 weeks
All-Cause Mortality
PLACEBO SPD489
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PLACEBO SPD489
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/185 (1.08%)      1/181 (0.55%)    
Injury, poisoning and procedural complications     
Fibula fracture  1/185 (0.54%)  1 0/181 (0.00%)  0
Lumbar vertebral fracture  0/185 (0.00%)  0 1/181 (0.55%)  1
Nervous system disorders     
Syncope  1/185 (0.54%)  1 0/181 (0.00%)  0
Psychiatric disorders     
Agitation  1/185 (0.54%)  1 0/181 (0.00%)  0
Anxiety  1/185 (0.54%)  1 0/181 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PLACEBO SPD489
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/185 (23.24%)      100/181 (55.25%)    
Gastrointestinal disorders     
Constipation  1/185 (0.54%)  1 10/181 (5.52%)  10
Diarrhoea  3/185 (1.62%)  3 11/181 (6.08%)  12
Dry mouth  11/185 (5.95%)  11 60/181 (33.15%)  60
Nausea  8/185 (4.32%)  9 16/181 (8.84%)  17
General disorders     
Fatigue  9/185 (4.86%)  12 17/181 (9.39%)  21
Feeling jittery  0/185 (0.00%)  0 10/181 (5.52%)  10
Metabolism and nutrition disorders     
Decreased appetite  3/185 (1.62%)  3 11/181 (6.08%)  11
Nervous system disorders     
Headache  16/185 (8.65%)  19 32/181 (17.68%)  37
Psychiatric disorders     
Insomnia  6/185 (3.24%)  6 19/181 (10.50%)  19
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: NCT01718509     History of Changes
Other Study ID Numbers: SPD489-344
2012-003310-14 ( EudraCT Number )
First Submitted: October 29, 2012
First Posted: October 31, 2012
Results First Submitted: July 17, 2014
Results First Posted: August 21, 2014
Last Update Posted: November 30, 2015