Clinical Trial Results:
The SPD489-344, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder
Summary
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EudraCT number |
2012-003310-14 |
Trial protocol |
ES IT |
Global end of trial date |
20 Sep 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
19 Sep 2018
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First version publication date |
01 Aug 2015
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
SPD489-344
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01718509 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Shire Development, LLC
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Sponsor organisation address |
725 Chesterbrook Boulevard, Wayne, United States, 19087
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Public contact |
Study Physician, Shire Development LLC, +1 8668425335,
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Scientific contact |
Study Physician, Shire Development LLC, +1 8668425335,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Sep 2013
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Sep 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To demonstrate the efficacy of SPD489 compared with placebo in adults (18-55 years of age inclusive) with moderate to severe binge eating disorder (BED) at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary.
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Protection of trial subjects |
The subject’s informed consent was a mandatory condition for taking part in the study. It was obtained in writing prior to the performance of any study-specific procedures.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Nov 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 20
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Country: Number of subjects enrolled |
United States: 370
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Worldwide total number of subjects |
390
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
390
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Subjects were recruited to participate at 41 sites in the United States and 2 sites in Germany. | ||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 390 subjects were randomized to treatment. Of these, 4 subjects in the placebo arm and 8 subjects in the SPD489 arm did not receive study drug. A total of 378 subjects started treatment. | ||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||
Blinding implementation details |
Both investigational products (SPD489 and placebo) were identical in appearance in order to protect the study blind.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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SPD489 | ||||||||||||||||||||||||||||||
Arm description |
Subjects received SPD489 for up to 12 weeks. | ||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
SPD489
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Investigational medicinal product code |
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Other name |
Lisdexamfetamine dimesylate
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
30, 50, or 70mg capsules administered once-daily. The starting dose was 30mg/day with subjects being individually titrated, based on efficacy and tolerability, to achieve an optimized dose (50 or 70mg/day) during the Dose-optimization Period. Following the Dose-optimization Period, subjects continued on their optimized dose for the duration of the 8-week Dose-maintenance Period.
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Arm title
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Placebo | ||||||||||||||||||||||||||||||
Arm description |
Subjects received placebo for up to 12 weeks | ||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo capsule administered once-daily
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Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: The numbers started represents the Safety Analysis Set, which included all randomized subjects who took at least 1 dose of investigational product and who had at least 1 follow-up safety assessment completed. |
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Baseline characteristics reporting groups
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Reporting group title |
SPD489
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Reporting group description |
Subjects received SPD489 for up to 12 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Subjects received placebo for up to 12 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
SPD489
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Reporting group description |
Subjects received SPD489 for up to 12 weeks. | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects received placebo for up to 12 weeks |
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End point title |
Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 | ||||||||||||
End point description |
Binge days were defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary.
The end point analyzed the Full Analysis Set (FAS), 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).
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End point type |
Primary
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End point timeframe |
Baseline and Visit 8 Which Spans Weeks 11/12
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Statistical analysis title |
Analysis of the number of binge days | ||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
350
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Mixed Models Repeated Measures Analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-1.66
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.04 | ||||||||||||
upper limit |
-1.28 |
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End point title |
Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | ||||||||||||
End point 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.
This end point analyzed the FAS, 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).
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End point type |
Secondary
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End point timeframe |
Up to 12 weeks
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Statistical analysis title |
Analysis of CGI-I scores | ||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
350
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Confidence interval |
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End point title |
Percent of Participants With a 4-Week Cessation From Binge Eating | ||||||||||||
End point description |
Four-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit.
This end point analyzed the FAS, 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).
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End point type |
Secondary
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End point timeframe |
Up to 12 weeks
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Statistical analysis title |
Analysis of 4-Week cessation from binge eating | ||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
350
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Confidence interval |
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End point title |
Percent Change From Baseline in Body Weight at Week 12 | ||||||||||||
End point description |
This end point analyzed the FAS, 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).
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End point type |
Secondary
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End point timeframe |
Baseline and week 12
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Statistical analysis title |
Analysis of body weight | ||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
350
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Mixed Models Repeated Measures Analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-5.41
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-6.39 | ||||||||||||
upper limit |
-4.44 |
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End point title |
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 | ||||||||||||
End point 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.
This end point analyzed the FAS, 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).
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End point type |
Secondary
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End point timeframe |
Baseline and week 12
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Statistical analysis title |
Analysis of Y-BOCS-BE total score | ||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
350
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 | ||||||||||||
Method |
Mixed Models Repeated Measures Analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-7.94
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-9.51 | ||||||||||||
upper limit |
-6.36 |
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End point title |
Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks | ||||||||||||
End point description |
This end point analyzed the FAS, 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).
Not all subjects had data for this outcome.
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End point type |
Secondary
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End point timeframe |
Baseline and up to 12 weeks
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Statistical analysis title |
Analysis of fasting triglyceride levels | ||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
309
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.002 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-0.196
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.321 | ||||||||||||
upper limit |
-0.07 |
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End point title |
Change From Baseline in Fasting Total Cholesterol Levels at Up to 12 Weeks | ||||||||||||
End point description |
This end point analyzed the FAS, 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).
Not all subjects had data for this outcome.
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End point type |
Secondary
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End point timeframe |
Baseline and up to 12 weeks
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Statistical analysis title |
Analysis of fasting total cholesterol levels | ||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
309
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.234 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-0.077
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.205 | ||||||||||||
upper limit |
0.05 |
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End point title |
Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks | ||||||||||||
End point description |
This end point analyzed the FAS, 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).
Not all subjects had data for this outcome.
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End point type |
Secondary
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End point timeframe |
Baseline and up to 12 weeks
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Statistical analysis title |
Analysis of hemoglobin A1c levels | ||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
310
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
= 0.185 | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
0.03
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.02 | ||||||||||||
upper limit |
0.08 |
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End point title |
Binge Eating Response | ||||||||||||||||||||||||
End point description |
Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows:
1) 1-week Cessation = 100% reduction in binge episodes during the preceding 7 days
2) Marked Reduction = 99% to 75% reduction during the time since the previous visit
3) Moderate Reduction = 74% to 50% reduction during the time since the previous visit
4) Negative to Minimal Reduction = <50% reduction during the time since the previous visit
This end point analyzed the FAS, 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).
Not all subjects had data for this outcome.
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End point type |
Secondary
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End point timeframe |
Up to 12 weeks
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Statistical analysis title |
Analysis of binge eating response | ||||||||||||||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
287
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||||||||||
P-value |
< 0.001 [1] | ||||||||||||||||||||||||
Method |
Cochran-Mantel-Haenszel | ||||||||||||||||||||||||
Confidence interval |
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Notes [1] - Multiplicity is not adjusted for this secondary efficacy end point in this study. |
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End point title |
Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12 | ||||||||||||
End point description |
This end point analyzed the FAS, 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).
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End point type |
Secondary
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End point timeframe |
Baseline and Visit 8 Which Spans Weeks 11/12
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Statistical analysis title |
Analysis of binge episodes per week | ||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
350
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 [2] | ||||||||||||
Method |
Mixed Models Repeated Measures Analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-2.23
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-2.77 | ||||||||||||
upper limit |
-1.69 | ||||||||||||
Notes [2] - Multiplicity is not adjusted for this secondary efficacy end point in this study. |
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End point title |
Change From Baseline in Eating Inventory Scores at Week 12 | |||||||||||||||||||||
End point 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.
This end point analyzed the FAS, 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).
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End point type |
Secondary
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End point timeframe |
Baseline and week 12
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Statistical analysis title |
Analysis of cognitive restraint of eating | |||||||||||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
350
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||
P-value |
= 0.011 [3] | |||||||||||||||||||||
Method |
Mixed Models Repeated Measures Analysis | |||||||||||||||||||||
Parameter type |
Least Squares Mean Difference | |||||||||||||||||||||
Point estimate |
1.27
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Confidence interval |
||||||||||||||||||||||
level |
95% | |||||||||||||||||||||
sides |
2-sided
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lower limit |
0.29 | |||||||||||||||||||||
upper limit |
2.24 | |||||||||||||||||||||
Notes [3] - Multiplicity is not adjusted for this secondary efficacy end point in this study. |
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Statistical analysis title |
Analysis of disinhibition of eating | |||||||||||||||||||||
Comparison groups |
SPD489 v Placebo
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Number of subjects included in analysis |
350
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||
P-value |
< 0.001 [4] | |||||||||||||||||||||
Method |
Mixed Models Repeated Measures Analysis | |||||||||||||||||||||
Parameter type |
Least Squares Mean Difference | |||||||||||||||||||||
Point estimate |
-3.6
|
|||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||
level |
95% | |||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||
lower limit |
-4.44 | |||||||||||||||||||||
upper limit |
-2.76 | |||||||||||||||||||||
Notes [4] - Multiplicity is not adjusted for this secondary efficacy end point in this study. |
||||||||||||||||||||||
Statistical analysis title |
Analysis of perceived hunger | |||||||||||||||||||||
Comparison groups |
SPD489 v Placebo
|
|||||||||||||||||||||
Number of subjects included in analysis |
350
|
|||||||||||||||||||||
Analysis specification |
Pre-specified
|
|||||||||||||||||||||
Analysis type |
superiority | |||||||||||||||||||||
P-value |
< 0.001 [5] | |||||||||||||||||||||
Method |
Mixed Models Repeated Measures Analysis | |||||||||||||||||||||
Parameter type |
Least Squares Mean Difference | |||||||||||||||||||||
Point estimate |
-4.21
|
|||||||||||||||||||||
Confidence interval |
||||||||||||||||||||||
level |
95% | |||||||||||||||||||||
sides |
2-sided
|
|||||||||||||||||||||
lower limit |
-5.09 | |||||||||||||||||||||
upper limit |
-3.33 | |||||||||||||||||||||
Notes [5] - Multiplicity is not adjusted for this secondary efficacy end point in this study. |
|
|||||||||||||
End point title |
Change From Baseline in Binge Eating Scale (BES) Score at Week 12 | ||||||||||||
End point 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.
This end point analyzed the FAS, 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).
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline and week 12
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Analysis of BES score | ||||||||||||
Comparison groups |
SPD489 v Placebo
|
||||||||||||
Number of subjects included in analysis |
350
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 [6] | ||||||||||||
Method |
Mixed Models Repeated Measures Analysis | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-9.28
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-11.44 | ||||||||||||
upper limit |
-7.12 | ||||||||||||
Notes [6] - Multiplicity is not adjusted for this secondary efficacy end point in this study. |
|
|||||||||||||
End point title |
Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks | ||||||||||||
End point 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.
This end point analyzed the FAS, 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).
Not all subjects had data for this outcome.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Baseline and up to 12 weeks
|
||||||||||||
|
|||||||||||||
Statistical analysis title |
Analysis of FrSBe Total Score | ||||||||||||
Comparison groups |
SPD489 v Placebo
|
||||||||||||
Number of subjects included in analysis |
311
|
||||||||||||
Analysis specification |
Pre-specified
|
||||||||||||
Analysis type |
superiority | ||||||||||||
P-value |
= 0.298 [7] | ||||||||||||
Method |
ANCOVA | ||||||||||||
Parameter type |
Least Squares Mean Difference | ||||||||||||
Point estimate |
-0.96
|
||||||||||||
Confidence interval |
|||||||||||||
level |
95% | ||||||||||||
sides |
2-sided
|
||||||||||||
lower limit |
-2.77 | ||||||||||||
upper limit |
0.85 | ||||||||||||
Notes [7] - Multiplicity is not adjusted for this secondary efficacy end point in this study. |
|
||||||||||||||||||||||||||||
End point title |
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility | |||||||||||||||||||||||||||
End point 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.
This end point analyzed the FAS, 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).
Not all subjects had data for this outcome.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Up to 12 weeks
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care | |||||||||||||||||||||||||||
End point 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.
This end point analyzed the FAS, 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).
Not all subjects had data for this outcome.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Up to 12 weeks
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities | |||||||||||||||||||||||||||
End point 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.
This end point analyzed the FAS, 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).
Not all subjects had data for this outcome.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Up to 12 weeks
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort | |||||||||||||||||||||||||||
End point 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.
This end point analyzed the FAS, 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).
Not all subjects had data for this outcome.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Up to 12 weeks
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression | |||||||||||||||||||||||||||
End point 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.
This end point analyzed the FAS, 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).
Not all subjects had data for this outcome.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Up to 12 weeks
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||
End point title |
Columbia-Suicide Severity Rating Scale (C-SSRS) | |||||||||||||||
End point 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.
This end point analyzed the Safety Analysis Set (SAS), 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.
|
|||||||||||||||
End point type |
Secondary
|
|||||||||||||||
End point timeframe |
Up to 12 weeks
|
|||||||||||||||
|
||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Amphetamine Cessation Symptom Assessment (ACSA) Total Score | ||||||||||||
End point 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.
This end point analyzed the SAS, 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.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to 12 weeks
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
13 weeks
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SPD489
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received SPD489 for up to 12 weeks | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Subjects received placebo for up to 12 weeks | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
Substantial protocol amendments (globally) |
|||
Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
12 Nov 2012 |
This amendment included the following important changes:
* Added an Overall Risk/Benefit Assessment to Section 1
* Changed comparison of the Y-BOCS-BE total score to a key secondary objective
* Added assessments of the EQ-5D-5L at Weeks 4, 6, 8, and 10 (Visits 4, 5, 6, and 7)
* Clarified inclusion criterion #7 to further describe indeterminate pregnancy test results
* Clarified exclusion criterion #1 to state a current diagnosis, rather than concurrent symptoms, of bulimia nervosa, or anorexia nervosa was exclusionary
* Added language regarding contraception requirements being reviewed at every study visit and document in source document
* Clarified language regarding use of psychoactive medications during the study and before study entry, and changed the language of the permitted window for psychotherapy
* Clarified that the MINI-Plus was to be used to exclude comorbid Axis I disorders rather than confirm diagnosis of BED
* Added further language addressing the management of positive responses on the C-SSRS
* Clarified that ACSA was to be collected at the Baseline Visit (Visit 0)
* Added a ±2-hour window to the 7:00 AM dosing instructions
* Added smoking status to items collected as part of medical history. |
||
Interruptions (globally) |
|||
Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |