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Trial record 19 of 594 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: NCT01718483
Recruitment Status : Completed
First Posted : October 31, 2012
Results First Posted : July 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 383
Recruitment Details Participants were recruited between 12-Nov-2012 and 19-June-2013 and locations included medical clinics & research centers.
Pre-assignment Details  
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description Placebo matching SPD489 capsule administered orally, once-daily, for up to 12 weeks. SPD489 capsule 30 (titration purpose only), 50 or 70 milligram (mg) administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Period Title: Overall Study
Started 191 192
Treated 187 192
Completed 157 158
Not Completed 34 34
Reason Not Completed
Withdrawal by Subject             14             12
Adverse Event             5             12
Lost to Follow-up             8             3
Protocol Violation             4             2
Not specified             1             4
Pregnancy             1             1
Lack of Efficacy             1             0
Arm/Group Title PLACEBO SPD489 Total
Hide Arm/Group Description Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks. SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached. Total of all reporting groups
Overall Number of Baseline Participants 187 192 379
Hide Baseline Analysis Population Description
Safety Analysis Set was used for Baseline Measures. The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Four participants did not receive investigational product, therefore n=379.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 187 participants 192 participants 379 participants
37.6  (10.21) 38.5  (10.4) 38.1  (10.3)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 187 participants 192 participants 379 participants
<40 years 102 98 200
>=40 years 85 94 179
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 187 participants 192 participants 379 participants
Female
163
  87.2%
165
  85.9%
328
  86.5%
Male
24
  12.8%
27
  14.1%
51
  13.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 187 participants 192 participants 379 participants
GERMANY 2 1 3
SPAIN 5 5 10
SWEDEN 15 13 28
UNITED STATES 165 173 338
1.Primary Outcome
Title Change From Baseline in the Number of Binge Days Per Week at Visit 8 (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 participant binge diary.
Time Frame Baseline and Visit 8 (Weeks 11-12)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 184 190
Least Squares Mean (Standard Error)
Unit of Measure: Binge days per week
-2.51  (0.125) -3.87  (0.124)
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 -1.35
Confidence Interval (2-Sided) 95%
-1.70 to -1.01
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores
Hide Description CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 184 190
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
47.3
(40.1 to 54.5)
82.1
(76.7 to 87.6)
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 Percentage 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
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 184 190
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
14.1
(9.1 to 19.2)
40.0
(33.0 to 47.0)
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 at Week 12
Hide Description [Not Specified]
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 184 190
Least Squares Mean (Standard Error)
Unit of Measure: percent change
0.11  (0.295) -6.25  (0.292)
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 -6.35
Confidence Interval (2-Sided) 95%
-7.17 to -5.54
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
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 183 188
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.28  (0.550) -15.68  (0.546)
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 -7.40
Confidence Interval (2-Sided) 95%
-8.93 to -5.88
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 Week 12/Early termination (ET)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 183 190
Least Squares Mean (Standard Error)
Unit of Measure: millimole per liter (mmol/L)
0.122  (0.0405) -0.077  (0.0393)
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.199
Confidence Interval (2-Sided) 95%
-0.310 to -0.088
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 Week 12/ET
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 183 190
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.094  (0.0435) -0.305  (0.0422)
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.211
Confidence Interval (2-Sided) 95%
-0.330 to -0.092
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 Week 12/ET
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 181 189
Least Squares Mean (Standard Error)
Unit of Measure: Percent hemoglobin
0.01  (0.016) -0.02  (0.015)
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 0.308
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.07 to 0.02
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. Percentage of participants with response was reported. 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 Week 12/ET
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 184 187
Measure Type: Number
Unit of Measure: percentage of participants
1-week cessation 26.6 47.1
Marked Reduction 15.2 31.6
Moderate Reduction 17.9 11.8
Negative to Minimal Reduction 40.2 9.6
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 (Weeks 11-12)
Hide Description [Not Specified]
Time Frame Baseline and Visit 8 (Weeks 11-12)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 184 190
Least Squares Mean (Standard Error)
Unit of Measure: Binge episodes per week
-3.49  (0.170) -5.27  (0.168)
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 -1.77
Confidence Interval (2-Sided) 95%
-2.24 to -1.30
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Eating Inventory Scores at Week 12
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 184 188
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Cognitive Restraint of Eating 1.63  (0.331) 3.27  (0.329)
Disinhibition of Eating -2.12  (0.286) -6.31  (0.285)
Perceived Hunger -1.90  (0.286) -6.60  (0.285)
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 <0.001
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 1.65
Confidence Interval (2-Sided) 95%
0.72 to 2.57
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 -4.19
Confidence Interval (2-Sided) 95%
-4.98 to -3.39
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 -4.70
Confidence Interval (2-Sided) 95%
-5.49 to -3.91
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 participant has greater control over eating behavior and 4 denoting that a participant 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
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 184 189
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-8.55  (0.763) -18.87  (0.755)
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 -10.32
Confidence Interval (2-Sided) 95%
-12.43 to -8.21
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Week 12
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. Participants 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 Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 182 187
Least Squares Mean (Standard Error)
Unit of Measure: t-scores
-3.09  (0.592) -3.40  (0.572)
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 0.706
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 -0.31
Confidence Interval (2-Sided) 95%
-1.93 to 1.31
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. Percentage of participants with various mobility conditions were reported.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 178 187
Measure Type: Number
Unit of Measure: percentage of participants
No problems walking about 82.6 87.2
Slight problems walking about 14.0 10.7
Moderate problems walking about 2.8 2.1
Severe problems walking about 0.6 0
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 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. Percentage of participants with various self-care conditions were reported.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 178 187
Measure Type: Number
Unit of Measure: percentage of participants
No problems washing or dressing 89.3 95.7
Slight problems washing or dressing 6.7 3.2
Moderate problems washing or dressing 3.9 1.1
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 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. Percentage of participants with various usual activities conditions were reported.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 177 186
Measure Type: Number
Unit of Measure: percentage of participants
No problems doing usual activities 78.0 87.1
Slight problems doing usual activities 14.7 9.7
Moderate problems doing usual activities 6.2 3.2
Severe problems doing usual activities 1.1 0
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 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. Percentage of participants with various pain/discomfort conditions were reported.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 178 187
Measure Type: Number
Unit of Measure: percentage of participants
No pain or discomfort 64.6 71.1
Slight pain or discomfort 27.5 20.9
Moderate pain or discomfort 7.3 7.5
Severe pain or discomfort 0.6 0.5
Extreme pain or discomfort 0 0
18.Secondary Outcome
Title EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression
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. Percentage of participants with various anxiety/depression conditions were reported.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 178 187
Measure Type: Number
Unit of Measure: percentage of participants
Not anxious or depressed 70.2 72.2
Slightly anxious or depressed 19.7 16.6
Moderately anxious or depressed 7.9 9.1
Severely anxious or depressed 2.2 1.6
Extremely anxious or depressed 0 0.5
19.Secondary Outcome
Title Columbia-Suicide Severity Rating Scale (C-SSRS)
Hide Description C-SSRS is a semi-structured interview that captures the occurrence, 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. Number of participants with suicidal ideation and suicidal behavior were reported.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 187 191
Measure Type: Number
Unit of Measure: participants
Suicidal Ideation 3 2
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
The Safety Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had at least 1 post-baseline safety assessment completed. Not all participants had data for this outcome.
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description:
Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
Overall Number of Participants Analyzed 138 155
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.3  (7.74) 5.7  (7.37)
Time Frame From first dose of study drug up to 3 days after the last dose at up to 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PLACEBO SPD489
Hide Arm/Group Description Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks. SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
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   2/187 (1.07%)      3/192 (1.56%)    
Hepatobiliary disorders     
Cholecystitis * 1  0/187 (0.00%)  0 1/192 (0.52%)  1
Immune system disorders     
Anaphylactic reaction * 1  1/187 (0.53%)  1 0/192 (0.00%)  0
Nervous system disorders     
Syncope * 1  0/187 (0.00%)  0 2/192 (1.04%)  2
Psychiatric disorders     
Conversion disorder * 1  1/187 (0.53%)  1 0/192 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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   67/187 (35.83%)      125/192 (65.10%)    
Gastrointestinal disorders     
Constipation * 1  4/187 (2.14%)  4 11/192 (5.73%)  11
Dry mouth * 1  16/187 (8.56%)  19 76/192 (39.58%)  86
Nausea * 1  14/187 (7.49%)  15 16/192 (8.33%)  19
General disorders     
Fatigue * 1  10/187 (5.35%)  11 7/192 (3.65%)  7
Feeling jittery * 1  2/187 (1.07%)  3 11/192 (5.73%)  13
Irritability * 1  13/187 (6.95%)  13 16/192 (8.33%)  18
Infections and infestations     
Upper respiratory tract infection * 1  11/187 (5.88%)  12 8/192 (4.17%)  10
Investigations     
Heart rate increased * 1  5/187 (2.67%)  5 14/192 (7.29%)  14
Metabolism and nutrition disorders     
Decreased appetite * 1  6/187 (3.21%)  6 17/192 (8.85%)  17
Nervous system disorders     
Headache * 1  17/187 (9.09%)  19 26/192 (13.54%)  32
Psychiatric disorders     
Anxiety * 1  2/187 (1.07%)  2 13/192 (6.77%)  13
Insomnia * 1  14/187 (7.49%)  15 34/192 (17.71%)  44
Skin and subcutaneous tissue disorders     
Hyperhidrosis * 1  1/187 (0.53%)  1 10/192 (5.21%)  10
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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: NCT01718483     History of Changes
Other Study ID Numbers: SPD489-343
2012-003309-91 ( EudraCT Number )
First Submitted: October 29, 2012
First Posted: October 31, 2012
Results First Submitted: March 18, 2014
Results First Posted: July 21, 2014
Last Update Posted: November 30, 2015