Trial · NCT01657019
Open Label Extension in Adults With Binge Eating Disorder (BED)
NCT01657019, Phase 3, Completed, Shire; results first posted 2015-12-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label Extension in Adults With Binge Eating Disorder (BED). Trials, record NCT01657019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01657019
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Extension in Adults With Binge Eating Disorder (BED)
- NCT number
- NCT01657019
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 604 participants, actual
- Lead sponsor
- Shire
- Conditions
- Binge Eating Disorder
- Interventions
- Lisdexamfetamine dimesylate
- First posted
- 2012-08-03
- Last updated
- 2021-06-09
- Other registries' IDs
- eudract:2012-003313-34
- Results first posted
- 2015-12-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety | 52 weeks | |
| Primary | Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) | 53 weeks | 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. |
| Secondary | Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale | Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) | 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. |
| Secondary | Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q) | Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) | 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. |
| Secondary | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 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. |
| Secondary | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 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. |
| Secondary | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 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. |
| Secondary | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 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. |
| Secondary | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety | 52 weeks | 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. | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) | 53 weeks | 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. | participants | NUMBER |
| SECONDARY | Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale | Weeks 1, 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) | 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. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in The Global Score for The Eating Disorder Examination Questionnaire (EDE-Q) | Baseline, Weeks 4, 24, and 52, and end of treatment (either Visit 16 [Week 52] or Early Termination) | 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. | units on a scale | MEAN |
| SECONDARY | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Mobility | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 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. | percentage of participants at ET | NUMBER |
| SECONDARY | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Self Care | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 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. | percentage of participants at ET | NUMBER |
| SECONDARY | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Usual Activities | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 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. | percentage of participants at ET | NUMBER |
| SECONDARY | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Pain and Discomfort | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 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. | percentage of participants at ET | NUMBER |
| SECONDARY | Percentage of Participants With a Response to The EuroQoL Group 5 Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) For Anxiety or Depression | End of Treatment (ET; either Visit 16 [Week 52] or Early Termination) | 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. | percentage of participants at ET | NUMBER |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety | All Participants | Any TEAE | 84.5 | percentage of participants | |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as a Measure of Safety | All Participants | Serious TEAEs | 2.8 | percentage of participants | |
| Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) | All Participants | Suicidal behavior | 0 | participants | |
| Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) | All Participants | Active suicidal ideation | 2 | participants | |
| Number of Participants With a Positive Response on The Columbia Suicide Severity Rating Scale (C-SSRS) | All Participants | Non-suicidal self-injurious behavior | 3 | participants | |
| Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale | All Participants | Visit 1 (Week 1), n=589 | 53.7 | 95% Confidence Interval 49.6 to 57.7 | percentage of participants |
| Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale | All Participants | Visit 4 (Week 4), n=572 | 88.5 | 95% Confidence Interval 85.8 to 91.1 | percentage of participants |
| Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale | All Participants | Visit 9 (Week 24), n=466 | 92.7 | 95% Confidence Interval 90.3 to 95.1 | percentage of participants |
| Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale | All Participants | Visit 16 (Week 52), n=369 | 95.4 | 95% Confidence Interval 93.2 to 97.5 | percentage of participants |
| Percentage of Participants With an Improved Response on The Clinical Global Impressions of Improvement (CGI-I) Scale | All Participants | End of Treatment, n=597 | 89.9 | 95% Confidence Interval 87.5 to 92.3 | percentage of participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | All Participants | 604 | |
| Overall Study | COMPLETED | All Participants | 369 | |
| Overall Study | NOT COMPLETED | All Participants | 235 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | All Participants | 41 | 599 | |
| other | Diarrhoea | Gastrointestinal disorders | All Participants | 26 | 599 | |
| other | Dry mouth | Gastrointestinal disorders | All Participants | 163 | 599 | |
| other | Nausea | Gastrointestinal disorders | All Participants | 41 | 599 | |
| other | Toothache | Gastrointestinal disorders | All Participants | 12 | 599 | |
| other | Vomiting | Gastrointestinal disorders | All Participants | 15 | 599 | |
| other | Fatigue | General disorders | All Participants | 28 | 599 | |
| other | Feeling jittery | General disorders | All Participants | 30 | 599 | |
| other | Irritability | General disorders | All Participants | 36 | 599 | |
| other | Gastroenteritis | Infections and infestations | All Participants | 14 | 599 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 447 | 599 |
| Total, serious adverse events | All Participants | 17 | 599 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28383364 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01657019
GET https://conductscience.org/api/trials/v1/NCT01657019/results?page=2