Clinical Trial Results:
A Phase 3, Multicenter, Double-blind, Placebo-controlled, Randomized-withdrawal Study to Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years with Moderate to Severe Binge Eating Disorder
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Summary
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EudraCT number |
2012-004457-88 |
Trial protocol |
SE DE ES |
Global end of trial date |
08 Apr 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Apr 2016
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First version publication date |
09 Apr 2016
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Other versions |
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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 |
SPD489-346
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02009163 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Shire Development LLC and International Affiliates
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Sponsor organisation address |
1200 Morris Drive, Wayne, United States, 19087
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Public contact |
Study Physician, Shire Development LLC and International Affiliates , +1 8668425335,
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Scientific contact |
Study Physician, Shire Development LLC and International Affiliates , +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 |
08 Apr 2015
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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 |
08 Apr 2015
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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 evaluate maintenance of efficacy based on time to relapse between SPD489 (50 or 70mg) and placebo, as measured by the number of binge days (defined as days during which at least 1 binge episode occurred) per week as assessed by clinical interview based on subject diary and Clinical Global Impression – Severity (CGI-S) scores for subjects who responded to SPD489 by the end of the Open-label Treatment Phase.
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Protection of trial subjects |
This study was conducted in accordance with International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Jan 2014
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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 |
Spain: 15
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Country: Number of subjects enrolled |
Sweden: 24
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Country: Number of subjects enrolled |
Germany: 37
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Country: Number of subjects enrolled |
Canada: 5
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Country: Number of subjects enrolled |
United States: 337
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Worldwide total number of subjects |
418
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EEA total number of subjects |
76
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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) |
418
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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 49 sites in the US (38 sites), Germany (6 sites), Sweden (2 sites), Spain (2 sites), and Canada (1 site). | |||||||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Subjects were screened for eligibility over a period of 4 weeks | |||||||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Open–label Period (Non-randomized)
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Is this the baseline period? |
Yes | |||||||||||||||||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||||||||||||||
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Arms
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Arm title
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SPD489 (Open-label Period) | |||||||||||||||||||||||||||||||||
Arm description |
SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4 week openlabel dose optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been downtitrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose optimization was maintained throughout the 8week dose maintenance period. The total time of the openlabel period was 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 |
Participants were administered one 30, 50, or 70mg capsule once daily.
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Period 2
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Period 2 title |
Randomized-withdrawal Period
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Is this the baseline period? |
No | |||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||||||||||||||
Blinding implementation details |
SPD489 and placebo were identical in appearance.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo (Randomized-withdrawal Period) | |||||||||||||||||||||||||||||||||
Arm description |
During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week | |||||||||||||||||||||||||||||||||
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 |
Participants were administered a placebo capsule once daily.
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Arm title
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SPD489 (Randomized-withdrawal Period) | |||||||||||||||||||||||||||||||||
Arm description |
For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week. | |||||||||||||||||||||||||||||||||
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 |
Participants were administered one 50 or 70mg capsule once daily.
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Baseline characteristics reporting groups
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Reporting group title |
Open–label Period (Non-randomized)
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Reporting group description |
All participants enrolled in the open-label population. | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
SPD489 (Open-label Period)
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Reporting group description |
SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4 week openlabel dose optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been downtitrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose optimization was maintained throughout the 8week dose maintenance period. The total time of the openlabel period was 12 weeks. | ||
Reporting group title |
Placebo (Randomized-withdrawal Period)
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Reporting group description |
During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week | ||
Reporting group title |
SPD489 (Randomized-withdrawal Period)
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Reporting group description |
For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week. | ||
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End point title |
Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period | ||||||||||||
End point description |
Relapse status was assessed during the doubleblind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global ImpressionsSeverity (CGIS) score of 2 or more points compared to the randomizedwithdrawal baseline (date of relapse date of randomization). Binge eating information was captured via a selfreport paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the participant to confirm reported binge episodes per day. The CGIS was performed to rate the severity of a participant's condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).
This endpoint assessed the Full Analysis Set (FAS
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End point type |
Primary
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End point timeframe |
Visit 21 (26 weeks after randomization [Week 38] or Early Termination). Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.
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| Notes [1] - Three subjects in the placebo group were randomized and included in the RSAS but not the FAS. [2] - For both arms, 9999 is used to indicate that the median time to relapse or range was not calculable. |
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Statistical analysis title |
Analysis of Relapse | ||||||||||||
Comparison groups |
Placebo (Randomized-withdrawal Period) v SPD489 (Randomized-withdrawal Period)
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Number of subjects included in analysis |
267
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 [3] | ||||||||||||
Method |
Logrank | ||||||||||||
Confidence interval |
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| Notes [3] - Pvalue based on a logrank test, stratified by 4week cessation status (Yes, No). 4week cessation was defined as a subject having no binge days during the 4 weeks prior to randomization. |
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End point title |
Change From Randomized-withdrawal Baseline in The Number of BingeEating Days Per Week During The Randomized-withdrawal Period | ||||||||||||
End point description |
A binge day was defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary. Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the participant to confirm reported binge episodes per day. A negative change from Baseline indicates that binge-related behavior decreased. The randomizedwithdrawal baseline was defined as the weekly average number of binge days for the 14 days prior to the Randomization Visit (Visit 8).
This endpoint assessed the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 included only participants who completed randomized treatment (placebo: n=50; SPD489: n=102).
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End point type |
Secondary
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End point timeframe |
Randomized-withdrawal baseline (Visit 8; 12 weeks after start of openlabel treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])
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| Notes [4] - Three subjects in the placebo group were randomized and included in the RSAS but not the FAS. |
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Statistical analysis title |
Analysis of Binge Eating Days | ||||||||||||
Comparison groups |
Placebo (Randomized-withdrawal Period) v SPD489 (Randomized-withdrawal Period)
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Number of subjects included in analysis |
267
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 [5] | ||||||||||||
Method |
mixedeffects model for repeated measure | ||||||||||||
Parameter type |
difference in LS mean | ||||||||||||
Point estimate |
-0.61
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-0.81 | ||||||||||||
upper limit |
-0.42 | ||||||||||||
| Notes [5] - Nominal P-value not adjusted for multiplicity. MMRM over all postrandomization visits during the randomizedwithdrawal phase. Value for change from baseline = outcome variable. |
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End point title |
Percent of Participants Within Each Category of The Clinical Global ImpressionSeverity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period | |||||||||||||||||||||||||||||||||
End point description |
The CGI-S permits a global evaluation of a participant's condition and severity of symptoms. The CGI-S was performed to rate the severity of a participant's condition based on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).
This endpoint assessed the FAS, defined as participants in the Randomized Safety Analysis Set (RSAS) with at least 1 post-randomization CGI-S assessment.
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End point type |
Secondary
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End point timeframe |
Visit 21 (26 weeks after randomization [Week 38] or Early Termination). Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.
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| Notes [6] - Three subjects in the placebo group were randomized and included in the RSAS but not the FAS. |
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Statistical analysis title |
Analysis of CGI-S | |||||||||||||||||||||||||||||||||
Comparison groups |
Placebo (Randomized-withdrawal Period) v SPD489 (Randomized-withdrawal Period)
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Number of subjects included in analysis |
267
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||||||||||||||||||||
P-value |
< 0.001 [7] | |||||||||||||||||||||||||||||||||
Method |
Cochran-Mantel-Haenszel | |||||||||||||||||||||||||||||||||
Confidence interval |
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| Notes [7] - Unadjusted Pvalue for the difference in distribution between treatment groups in CGIS. Cochran-Mantel-Haenszel test with a modified ridit score, adjusting for Visit 8 (Week 12) CGIS as the covariate. |
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End point title |
Change From Randomized-withdrawal Baseline in The Total Score of The Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) During The Randomized-withdrawal Period | ||||||||||||
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). The scale includes questions regarding the amount of time spent on obsessions, impairment or distress experienced, and resistance and control over these thoughts. The same types of questions were asked about compulsions (ie, time spent, interference, etc.).Total scores range from 0 to 40. A total score of 0-7 is subclinical, 8-15 is mild, 16-23 is moderate, 24-31 is severe, and 32-40 is extreme. A decrease from baseline in Y-BOCS-BE Total Score represents an improvement in obsession with bingeeating thoughts or compulsiveness of binge-eating behaviors.
The endpoint assessed the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 included only participants who completed randomized treatment (placebo: n=54; SPD489: n=107).
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End point type |
Secondary
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End point timeframe |
Randomizedwithdrawal baseline (Visit 8; 12 weeks after start of openlabel treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38])
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| Notes [8] - Three subjects in the placebo group were randomized and included in the RSAS but not the FAS. |
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Statistical analysis title |
Analysis of Y-BOCS-BE | ||||||||||||
Comparison groups |
Placebo (Randomized-withdrawal Period) v SPD489 (Randomized-withdrawal Period)
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Number of subjects included in analysis |
267
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.001 [9] | ||||||||||||
Method |
mixedeffects model for repeated measure | ||||||||||||
Parameter type |
difference in LS mean | ||||||||||||
Point estimate |
-5.6
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-7.2 | ||||||||||||
upper limit |
-3.9 | ||||||||||||
| Notes [9] - Nominal P-value not adjusted for multiplicity. MMRM over all postrandomization visits during the randomizedwithdrawal phase. Value for change from baseline = outcome variable. |
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End point title |
Percent of Participants Within Each Category of The Euro-Quol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of the Open-label Period | ||||||||||||||||||
End point description |
The EuroQoL Group 5Dimension 5Level SelfReport Questionnaire (EQ-5D-5L) is a healthrelated quality of life (QoL) measure that assesses mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5item descriptive system that measures 5 dimensions of health, including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.
This endpoint assessed the Open-label Safety Population (OSP), defined as participants who had taken at least 1 dose of SPD489 in the openlabel period and who had a postbaseline safety assessment. Not all participants had data collected for this outcome.
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End point type |
Secondary
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End point timeframe |
Visit 8 (12 weeks after start of openlabel treatment [Week 12] or Early Termination). Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility at Endpoint of the Randomized-withdrawal Period | |||||||||||||||||||||||||||
End point description |
The EuroQoL Group 5Dimension 5Level SelfReport Questionnaire (EQ-5D-5L) is a healthrelated quality of life (QoL) measure that assesses mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5item descriptive system that measures 5 dimensions of health, including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.
This endpoint assessed the FAS. Not all participants in the FAS had data collected for this outcome.
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End point type |
Secondary
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End point timeframe |
Visit 21 (26 weeks after randomization [Week 38] or Early Termination). Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.
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| Notes [10] - Three subjects in the placebo group were randomized and included in the RSAS but not the FAS. |
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||
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End point title |
Percent of Participants Within Each Category of The Euro-Quol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of the Open-label Period | ||||||||||||||||||
End point description |
The EuroQoL Group 5Dimension 5Level SelfReport Questionnaire (EQ-5D-5L) is a healthrelated quality of life (QoL) measure that assesses mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5item descriptive system that measures 5 dimensions of health, including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.
This endpoint assessed the Open-label Safety Population (OSP), defined as participants who had taken at least 1 dose of SPD489 in the openlabel period and who had a postbaseline safety assessment. Not all participants had data collected for this outcome.
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End point type |
Secondary
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End point timeframe |
Visit 8 (12 weeks after start of openlabel treatment [Week 12] or Early Termination). Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care at Endpoint of the Randomized-withdrawal Period | |||||||||||||||||||||||||||
End point description |
The EuroQoL Group 5Dimension 5Level SelfReport Questionnaire (EQ-5D-5L) is a healthrelated quality of life (QoL) measure that assesses mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5item descriptive system that measures 5 dimensions of health, including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.
This endpoint assessed the FAS. Not all participants in the FAS had data collected for this outcome.
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End point type |
Secondary
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End point timeframe |
Visit 21 (26 weeks after randomization [Week 38] or Early Termination). Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| Notes [11] - Three subjects in the placebo group were randomized and included in the RSAS but not the FAS |
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
|||||||||||||||||||
End point title |
Percent of Participants Within Each Category of The Euro-Quol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of the Open-label Period | ||||||||||||||||||
End point description |
The EuroQoL Group 5Dimension 5Level SelfReport Questionnaire (EQ-5D-5L) is a healthrelated quality of life (QoL) measure that assesses mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5item descriptive system that measures 5 dimensions of health, including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.
This endpoint assessed the Open-label Safety Population (OSP), defined as participants who had taken at least 1 dose of SPD489 in the openlabel period and who had a postbaseline safety assessment. Not all participants had data collected for this outcome.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Visit 8 (12 weeks after start of openlabel treatment [Week 12] or Early Termination). Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities at Endpoint of the Randomized-withdrawal Period | |||||||||||||||||||||||||||
End point description |
The EuroQoL Group 5Dimension 5Level SelfReport Questionnaire (EQ-5D-5L) is a healthrelated quality of life (QoL) measure that assesses mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5item descriptive system that measures 5 dimensions of health, including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.
This endpoint assessed the FAS. Not all participants in the FAS had data collected for this outcome.
|
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End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Visit 21 (26 weeks after randomization [Week 38] or Early Termination). Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| Notes [12] - Three subjects in the placebo group were randomized and included in the RSAS but not the FAS. |
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
|||||||||||||||||||
End point title |
Percent of Participants Within Each Category of The Euro-Quol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain And Discomfort at Endpoint of the Open-label Period | ||||||||||||||||||
End point description |
The EuroQoL Group 5Dimension 5Level SelfReport Questionnaire (EQ-5D-5L) is a healthrelated quality of life (QoL) measure that assesses mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5item descriptive system that measures 5 dimensions of health, including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.
This endpoint assessed the Open-label Safety Population (OSP), defined as participants who had taken at least 1 dose of SPD489 in the openlabel period and who had a postbaseline safety assessment. Not all participants had data collected for this outcome.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Visit 8 (12 weeks after start of openlabel treatment [Week 12] or Early Termination). Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain And Discomfort at Endpoint of the Randomized-withdrawal Period | |||||||||||||||||||||||||||
End point description |
The EuroQoL Group 5Dimension 5Level SelfReport Questionnaire (EQ-5D-5L) is a healthrelated quality of life (QoL) measure that assesses mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5item descriptive system that measures 5 dimensions of health, including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.
This endpoint assessed the FAS. Not all participants in the FAS had data collected for this outcome.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Visit 21 (26 weeks after randomization [Week 38] or Early Termination). Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| Notes [13] - Three subjects in the placebo group were randomized and included in the RSAS but not the FAS. |
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
|||||||||||||||||||
End point title |
Percent of Participants Within Each Category of The Euro-Quol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of the Open-label Period | ||||||||||||||||||
End point description |
The EuroQoL Group 5Dimension 5Level SelfReport Questionnaire (EQ-5D-5L) is a healthrelated quality of life (QoL) measure that assesses mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5item descriptive system that measures 5 dimensions of health, including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.
This endpoint assessed the Open-label Safety Population (OSP), defined as participants who had taken at least 1 dose of SPD489 in the openlabel period and who had a postbaseline safety assessment. Not all participants had data collected for this outcome.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Visit 8 (12 weeks after start of openlabel treatment [Week 12] or Early Termination). Visit 8 could include participants who discontinued but completed a safety and efficacy assessment.
|
||||||||||||||||||
|
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
||||||||||||||||||||||||||||
End point title |
Percent of Participants Within Each Category of The EuroQuol Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety And Depression at Endpoint of the Randomized-withdrawal Period | |||||||||||||||||||||||||||
End point description |
The EuroQoL Group 5Dimension 5Level SelfReport Questionnaire (EQ-5D-5L) is a healthrelated quality of life (QoL) measure that assesses mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. It consists of a 5item descriptive system that measures 5 dimensions of health, including mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health.
This endpoint assessed the FAS. Not all participants in the FAS had data collected for this outcome.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Visit 21 (26 weeks after randomization [Week 38] or Early Termination). Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment.
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
| Notes [14] - Three subjects in the placebo group were randomized and included in the RSAS but not the FAS. |
||||||||||||||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||||||||||||||
|
|||||||||||||
End point title |
Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Open-label Period | ||||||||||||
End point description |
The C-SSRS is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. It includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. "Yes" answers to the first 2 ideation questions led the clinician to ask questions 3-5. Active suicidal ideation included any "yes" answer to questions 2-5. If the answers to ideation questions 1 and 2 were "No," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide.
This endpoint assessed the OSP.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Visit 8 (12 weeks after start of openlabel treatment [Week 12]). Visit 8 included only participants who completed open-label treatment.
|
||||||||||||
|
|||||||||||||
| Notes [15] - Three participants in the OSP did not have data collected for this outcome. |
|||||||||||||
| No statistical analyses for this end point | |||||||||||||
|
|||||||||||||||||||
End point title |
Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) at Endpoint of The Randomized-withdrawal Period | ||||||||||||||||||
End point description |
The C-SSRS is a semistructured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors. It includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. "Yes" answers to the first 2 ideation questions led the clinician to ask questions 3-5. Active suicidal ideation included any "yes" answer to questions 2-5. If the answers to ideation questions 1 and 2 were "No," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide.
This endpoint assessed the RSAS.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Visit 21 (26 weeks after randomization [Week 38] or Early Termination).
|
||||||||||||||||||
|
|||||||||||||||||||
| Notes [16] - Four subjects were randomized but not treated and thus not included in the RSAS. [17] - One subject was randomized but not treated and thus not included in the RSAS. |
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||
End point title |
Total Scores For The Amphetamine Cessation Symptom Assessment (ACSA) Scale During Followup | ||||||||||||||||||
End point description |
The ACSA was used in this study to assess potential withdrawal symptoms associated with chronic use of SPD489. The ACSA is a selfcompleted scale used to assess withdrawal symptoms. The scale has 16 symptom items rated on a 5point scale ranging from 0 (not at all) to 4 (extremely). The ACSA total score ranges from 064, where a higher score indicates greater withdrawal symptom severity.
The endpoint assessed the Randomized Safety Analysis Set (RSAS), defined as participants in the SAS who were randomized and took at least 1 dose of investigational product in the randomizedwithdrawal period. Not all participants had data for this or the previous outcome.
|
||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||
End point timeframe |
Visit 21 (26 weeks after randomization [Week 38] or Early Termination) and Visit 22 (7 days post last dose). Visits 21 and 22 could include participants who discontinued but completed a final safety and efficacy assessment.
|
||||||||||||||||||
|
|||||||||||||||||||
| Notes [18] - Four subjects were randomized but not treated and thus not included in the RSAS. [19] - One subject was randomized but not treated and thus not included in the RSAS. |
|||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
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Timeframe for reporting adverse events |
39 weeks
|
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
|
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Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SPD489 (Open-label Period)
|
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Reporting group description |
SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4 week openlabel dose optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been downtitrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose optimization was maintained throughout the 8week dose maintenance period. The total time of the open label period was 12 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo (Randomized-withdrawal Period)
|
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Reporting group description |
During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week . | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
SPD489 (Randomized-withdrawal Period)
|
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Reporting group description |
For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 2% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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30 Sep 2013 |
This amendment included the following important changes:
* Updated the number of participating sites and countries
* Added region (North America, non-North America) as a stratification factor for Randomization
* Added SDS and PRUQ-BED as exploratory efficacy endpoints
* Clarified collection times for pharmacogenomic samples
* Updated duration between study visits
* Increased the number of Y-BOCS-BE assessments during the double-blind randomized withdrawal phase
* Added the SDS as a health-related quality of life assessment
* Added change from randomized baseline in SDS total score as an exploratory objective
* Clarified that the date of relapse should be captured in the source documents and on the case report form
* Added clarification for the review and documentation of contraceptive requirements for FOCPs
* Added “failure to meet randomization criteria” as a reason for discontinuation
* Added “met relapse criteria” as a reason for discontinuation
* Added details for data input regarding stratum assignment during randomization and relapse assessment using IWRS
* Clarified process for assessing abnormal ECG results
* Clarified the purpose of the MINI-plus
* Clarified binge frequency to be reviewed by clinician and subject to confirm reported binge episodes per day
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
