Trial Outcomes & Findings for Open Label Extension in Adults With Binge Eating Disorder (BED) (NCT NCT01657019)
NCT ID: NCT01657019
Last Updated: 2021-06-09
Results Overview
COMPLETED
PHASE3
604 participants
52 weeks
2021-06-09
Participant Flow
This was an open-label extension study to evaluate the long-term safety of SPD489 in adults aged 18-55 years with binge eating disorder (BED) who completed 1 of 3 antecedent studies, all of which tested SPD489 for BED (SPD489-208, SPD489-343, or SPD489-344).
Participant milestones
| Measure |
All Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
|
|---|---|
|
Overall Study
STARTED
|
604
|
|
Overall Study
COMPLETED
|
369
|
|
Overall Study
NOT COMPLETED
|
235
|
Reasons for withdrawal
| Measure |
All Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
65
|
|
Overall Study
Adverse Event
|
55
|
|
Overall Study
Lost to Follow-up
|
48
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Other
|
58
|
Baseline Characteristics
Open Label Extension in Adults With Binge Eating Disorder (BED)
Baseline characteristics by cohort
| Measure |
All Participants
n=599 Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
|
|---|---|
|
Age, Continuous
|
39.0 years
STANDARD_DEVIATION 9.98 • n=5 Participants
|
|
Age, Customized
< 40 years
|
301 Participants
n=5 Participants
|
|
Age, Customized
>/= 40 years
|
298 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
521 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
Outcome measures
| Measure |
All Participants
n=599 Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
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|---|---|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety
Any TEAE
|
84.5 percentage of participants
|
|
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety
Serious TEAEs
|
2.8 percentage of participants
|
PRIMARY outcome
Timeframe: 53 weeksPopulation: The Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. 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. If the answers to the first 2 ideation questions were "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" 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.
Outcome measures
| Measure |
All Participants
n=597 Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
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|---|---|
|
Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)
Suicidal behavior
|
0 participants
|
|
Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)
Active suicidal ideation
|
2 participants
|
|
Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS)
Non-suicidal self-injurious behavior
|
3 participants
|
SECONDARY outcome
Timeframe: Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)Population: The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
The CGI rating scales permitted the global evaluation of a participant's condition severity and improvement over time. The CGI-I was performed to rate the improvement of a participant's condition on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse) and included a 'not assessed' option. The responses were dichotomized into 2 categories (improved or not improved). Improved included very much improved and much improved; not improved included minimally improved, no change, minimally worse, much worse, and very much worse. Not assessed and missing values were excluded from the percentage calculation.
Outcome measures
| Measure |
All Participants
n=597 Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
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|---|---|
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Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale
Visit 1 (Week 1), n=589
|
53.7 percentage of participants
Interval 49.6 to 57.7
|
|
Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale
Visit 4 (Week 4), n=572
|
88.5 percentage of participants
Interval 85.8 to 91.1
|
|
Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale
Visit 9 (Week 24), n=466
|
92.7 percentage of participants
Interval 90.3 to 95.1
|
|
Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale
Visit 16 (Week 52), n=369
|
95.4 percentage of participants
Interval 93.2 to 97.5
|
|
Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale
End of Treatment, n=597
|
89.9 percentage of participants
Interval 87.5 to 92.3
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination)Population: The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
The EDE-Q is a 28-item questionnaire measuring eating pathology and is derived directly from the Eating Disorder Examination Interview. The EDE-Q focuses on the past 28 days to assess the main behavioral (eating and purging) and attitudinal features of eating disorders. The 28 items are rated by the participant on a 7-point scale (ranging from 0 to 6), with higher scores indicating increased pathology. The EDE-Q includes 4 subscales: Restraint, Eating Concern, Weight Concern, and Shape Concern. The global score is the average of all 28 items, with a range of 0 to 6. A negative value indicates a favorable result. The values presented are the mean change from baseline.
Outcome measures
| Measure |
All Participants
n=597 Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
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|---|---|
|
Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)
Visit 4 (Week 4), n=483
|
-1.66 units on a scale
Standard Deviation 1.156
|
|
Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)
Visit 9 (Week 24), n=391
|
-1.95 units on a scale
Standard Deviation 1.271
|
|
Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)
Visit 16 (Week 52), n=314
|
-1.95 units on a scale
Standard Deviation 1.261
|
|
Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q)
End of Treatment, n=503
|
-1.90 units on a scale
Standard Deviation 1.284
|
SECONDARY outcome
Timeframe: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)Population: The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
The EQ-5D-5L 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. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the mobility questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.
Outcome measures
| Measure |
All Participants
n=555 Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
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|---|---|
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Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility
I am unable to walk about
|
0.2 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility
I have slight problems in walking about
|
6.8 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility
I have moderate problems in walking about
|
1.4 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility
I have severe problems in walking about
|
0.4 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility
I have no problems in walking about
|
91.2 percentage of participants at ET
|
SECONDARY outcome
Timeframe: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)Population: The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
The EQ-5D-5L 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. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the self care questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.
Outcome measures
| Measure |
All Participants
n=555 Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
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|---|---|
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Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care
I have no problems washing or dressing myself
|
97.1 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care
I have slight problems washing or dressing myself
|
1.8 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care
Moderate problems washing or dressing myself
|
0.7 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care
I have severe problems washing or dressing myself
|
0.2 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care
I am unable to wash or dress myself
|
0.2 percentage of participants at ET
|
SECONDARY outcome
Timeframe: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)Population: The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
The EQ-5D-5L 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. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the usual activities questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.
Outcome measures
| Measure |
All Participants
n=555 Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
|
|---|---|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities
I have no problems doing my usual activities
|
88.5 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities
I am unable to do my usual activities
|
0.2 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities
I have slight problems doing my usual activities
|
8.3 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities
Moderate problems doing my usual activities
|
2.2 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities
I have severe problems doing my usual activities
|
0.9 percentage of participants at ET
|
SECONDARY outcome
Timeframe: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)Population: The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
The EQ-5D-5L 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. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the pain/discomfort questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.
Outcome measures
| Measure |
All Participants
n=555 Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
|
|---|---|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort
I have slight pain or discomfort
|
20.9 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort
I have moderate pain or discomfort
|
7.0 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort
I have no pain or discomfort
|
71.2 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort
I have severe pain or discomfort
|
0.9 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort
I have extreme pain or discomfort
|
0 percentage of participants at ET
|
SECONDARY outcome
Timeframe: End of Treatment (ET; either Visit 16 [Week 52] or Early Termination)Population: The Full Analysis Set, defined as all participants in the Safety Analysis Set who had at least 1 post-Visit 0 clinical experience outcome assessment in this study. The Safety Analysis Set was defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
The EQ-5D-5L 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. Each dimension is represented by a single item with 5 levels of responses, from poor health to good health. The percentages of participants with various responses to the anxiety/depression questionnaire are reported. Percentages are based on all participants in the Full Analysis Set with a valid result at the given visit.
Outcome measures
| Measure |
All Participants
n=555 Participants
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
|
|---|---|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression
I am severely anxious or depressed
|
0.9 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression
I am extremely anxious or depressed
|
0 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression
I am not anxious or depressed
|
75.9 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression
I am slightly anxious or depressed
|
18.7 percentage of participants at ET
|
|
Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression
I am moderately anxious or depressed
|
4.5 percentage of participants at ET
|
Adverse Events
All Participants
Serious adverse events
| Measure |
All Participants
n=599 participants at risk
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
|
|---|---|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Pneumonia
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Investigations
Liver function test abnormal
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.33%
2/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Psychiatric disorders
Adjustment disorder with anxiety
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Psychiatric disorders
Anxiety
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Helicobacter infection
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Diverticulitis
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
General disorders
Chest pain
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.17%
1/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
Other adverse events
| Measure |
All Participants
n=599 participants at risk
Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
6.8%
41/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
26/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Gastrointestinal disorders
Dry mouth
|
27.2%
163/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Gastrointestinal disorders
Nausea
|
6.8%
41/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Gastrointestinal disorders
Toothache
|
2.0%
12/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
15/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
General disorders
Fatigue
|
4.7%
28/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
General disorders
Feeling jittery
|
5.0%
30/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
General disorders
Irritability
|
6.0%
36/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Gastroenteritis
|
2.3%
14/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Gastroenteritis viral
|
3.0%
18/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Influenza
|
2.7%
16/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
53/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Sinusitis
|
5.8%
35/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.4%
68/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Infections and infestations
Urinary tract infection
|
4.5%
27/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Investigations
Blood pressure increased
|
4.3%
26/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Investigations
Heart rate increased
|
2.5%
15/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Investigations
Weight decreased
|
3.2%
19/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.0%
36/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
16/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
16/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Nervous system disorders
Dizziness
|
3.5%
21/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Nervous system disorders
Headache
|
13.2%
79/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Nervous system disorders
Hypoaesthesia
|
2.5%
15/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Nervous system disorders
Paraesthesia
|
2.3%
14/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Psychiatric disorders
Anxiety
|
5.0%
30/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Psychiatric disorders
Bruxism
|
5.8%
35/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Psychiatric disorders
Initial insomnia
|
4.2%
25/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Psychiatric disorders
Insomnia
|
12.4%
74/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.7%
16/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
|
Cardiac disorders
Tachycardia
|
2.3%
14/599
Adverse events were assessed for the Safety Analysis Set, defined as all participants who took at least 1 dose of investigational product and who had at least 1 post-Visit 0 safety assessment in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER