Trial · NCT02009163
Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
NCT02009163, Phase 3, Completed, Shire; results first posted 2016-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder. Trials, record NCT02009163. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02009163
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
- NCT number
- NCT02009163
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 418 participants, actual
- Lead sponsor
- Shire
- Conditions
- Binge Eating Disorder
- Interventions
- Lisdexamfetamine dimesylate, Placebo
- First posted
- 2013-12-11
- Last updated
- 2021-06-14
- Other registries' IDs
- eudract:2012-004457-88
- Results first posted
- 2016-04-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period | Visit 21 (26 weeks after randomization [Week 38] or Early Termination) | Relapse status was assessed during the double-blind 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 Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse - date of randomization). 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 subject to confirm reported binge episodes per day. The CGI-S was performed to rate the severity of a subject's condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). |
| Secondary | Change From Randomized-Withdrawal Baseline in The Number of Binge- Eating Days Per Week During The Randomized-withdrawal Period | Randomized--withdrawal baseline (Visit 8; 12 weeks after start of open- label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38]) | A binge day was defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject 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 subject to confirm reported binge episodes per day. A negative change from Baseline indicates that binge-related behavior decreased. The randomized -withdrawal-baseline was defined as the weekly average number of binge days for the 14 days prior to the Randomization Visit (Visit 8). |
| Secondary | Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period | Visit 21 (26 weeks after randomization [Week 38] or Early Termination) | The CGI-S permits a global evaluation of a subject's condition and severity of symptoms. The CGI-S was performed to rate the severity of a subject's condition based on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). |
| Secondary | 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 | Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38]) | 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 sub-clinical, 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 binge-eating thoughts or compulsiveness of binge-eating behaviors. |
| Secondary | 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 Open-label Period | Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) | The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. 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. |
| Secondary | 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 | Visit 21 (26 weeks after randomization [Week 38] or Early Termination) | The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. 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. |
| Secondary | 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 Open-label Period | Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) | The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. 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. |
| Secondary | 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 | Visit 21 (26 weeks after randomization [Week 38] or Early Termination) | The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. 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. |
| Secondary | 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 Open-label Period | Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) | The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. 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. |
| Secondary | 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 | Visit 21 (26 weeks after randomization [Week 38] or Early Termination) | The EuroQoL Group 5-Dimension 5-Level Self-Report Questionnaire (EQ-5D-5L) is a health-related quality of life (QoL) measure that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression as well as current overall health. 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period | Visit 21 (26 weeks after randomization [Week 38] or Early Termination) | The Full Analysis Set (FAS): participants in the Randomized Safety Analysis Set (RSAS) with at least 1 post-randomization CGI-S assessment. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment. | days | MEDIAN |
| SECONDARY | Change From Randomized-Withdrawal Baseline in The Number of Binge- Eating Days Per Week During The Randomized-withdrawal Period | Randomized--withdrawal baseline (Visit 8; 12 weeks after start of open- label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38]) | The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in 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). | days | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period | Visit 21 (26 weeks after randomization [Week 38] or Early Termination) | The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | 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 | Randomized-withdrawal baseline (Visit 8; 12 weeks after start of open-label treatment [Week 12]), Visit 21 (26 weeks after randomization [Week 38]) | The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in 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). | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | 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 Open-label Period | Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) | The Open-label Safety Population (OSP), defined as participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | 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 | Visit 21 (26 weeks after randomization [Week 38] or Early Termination) | The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | 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 Open-label Period | Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) | The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | 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 | Visit 21 (26 weeks after randomization [Week 38] or Early Termination) | The FAS. Three participants in the placebo group were randomized and included in the RSAS but not included in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | 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 Open-label Period | Visit 8 (12 weeks after start of open-label treatment [Week 12] or Early Termination) | The OSP. Not all participants had data collected for this outcome. Visit 8 could include participants who discontinued but completed a safety and efficacy assessment. | percentage of participants | NUMBER |
| SECONDARY | 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 | Visit 21 (26 weeks after randomization [Week 38] or Early Termination) | The FAS. Three participants in the placebo group were randomized and included in the RSAS but not in the FAS. Not all participants in the FAS had data collected for this outcome. Visit 21 could include participants who discontinued but completed a final safety and efficacy assessment. | percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group108
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period | Placebo (Randomized-withdrawal Period) | NA | Inter-Quartile Range 55.0 to NA | days | |
| Time to Relapse From Date of Randomization to Endpoint of The Randomized-withdrawal Period | SPD489 (Randomized-withdrawal Period) | NA | Inter-Quartile Range NA to NA | days | |
| Change From Randomized-Withdrawal Baseline in The Number of Binge- Eating Days Per Week During The Randomized-withdrawal Period | Placebo (Randomized-withdrawal Period) | 0.63 | Standard Error 0.076 | days | |
| Change From Randomized-Withdrawal Baseline in The Number of Binge- Eating Days Per Week During The Randomized-withdrawal Period | SPD489 (Randomized--Withdrawal Period) | 0.02 | Standard Error 0.061 | days | |
| Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period | Placebo (Randomized-withdrawal Period) | Normal, Not at All Ill | 45.0 | percentage of participants | |
| Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period | SPD489 (Randomized-withdrawal Period) | Normal, Not at All Ill | 81.6 | percentage of participants | |
| Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period | Placebo (Randomized-withdrawal Period) | Borderline Mentally Ill | 10.7 | percentage of participants | |
| Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period | SPD489 (Randomized-withdrawal Period) | Borderline Mentally Ill | 11.8 | percentage of participants | |
| Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period | Placebo (Randomized-withdrawal Period) | Mildly Ill | 14.5 | percentage of participants | |
| Percent of Participants Within Each Category of The Clinical Global Impression-Severity of Illness (CGI-S) Scale at Endpoint of The Randomized-withdrawal Period | SPD489 (Randomized-withdrawal Period) | Mildly Ill | 2.2 | percentage of participants |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Open-label Period (Non-randomized) | STARTED | SPD489 (Open-label Period) | 418 | |
| Open-label Period (Non-randomized) | STARTED | Placebo (Randomized-withdrawal Period) | 0 | |
| Open-label Period (Non-randomized) | STARTED | SPD489 (Randomized-withdrawal Period) | 0 | |
| Open-label Period (Non-randomized) | COMPLETED | SPD489 (Open-label Period) | 275 | |
| Open-label Period (Non-randomized) | COMPLETED | Placebo (Randomized-withdrawal Period) | 0 | |
| Open-label Period (Non-randomized) | COMPLETED | SPD489 (Randomized-withdrawal Period) | 0 | |
| Open-label Period (Non-randomized) | NOT COMPLETED | SPD489 (Open-label Period) | 143 | |
| Open-label Period (Non-randomized) | NOT COMPLETED | Placebo (Randomized-withdrawal Period) | 0 | |
| Open-label Period (Non-randomized) | NOT COMPLETED | SPD489 (Randomized-withdrawal Period) | 0 | |
| Randomized-withdrawal Period | STARTED | SPD489 (Open-label Period) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events117
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 | Dry mouth | Gastrointestinal disorders | SPD489 (Open-label Period) | 139 | 411 | 145 |
| other | Dry mouth | Gastrointestinal disorders | Placebo (Randomized-withdrawal Period) | 2 | 134 | 2 |
| other | Dry mouth | Gastrointestinal disorders | SPD489 (Randomized-withdrawal Period) | 7 | 136 | 7 |
| other | Headache | Nervous system disorders | SPD489 (Open-label Period) | 66 | 411 | 84 |
| other | Headache | Nervous system disorders | Placebo (Randomized-withdrawal Period) | 9 | 134 | 9 |
| other | Headache | Nervous system disorders | SPD489 (Randomized-withdrawal Period) | 12 | 136 | 14 |
| other | Insomnia | Psychiatric disorders | SPD489 (Open-label Period) | 46 | 411 | 46 |
| other | Insomnia | Psychiatric disorders | Placebo (Randomized-withdrawal Period) | 2 | 134 | 2 |
| other | Insomnia | Psychiatric disorders | SPD489 (Randomized-withdrawal Period) | 1 | 136 | 1 |
| other | Decreased appetite | Metabolism and nutrition disorders | SPD489 (Open-label Period) | 38 | 411 | 44 |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SPD489 (Open-label Period) | ||
| Total, all-cause mortality | Placebo (Randomized-withdrawal Period) | ||
| Total, all-cause mortality | SPD489 (Randomized-withdrawal Period) | ||
| Total, other adverse events | SPD489 (Open-label Period) | 303 | 411 |
| Total, other adverse events | Placebo (Randomized-withdrawal Period) | 45 | 134 |
| Total, other adverse events | SPD489 (Randomized-withdrawal Period) | 59 | 136 |
| Total, serious adverse events | SPD489 (Open-label Period) | 3 | 411 |
| Total, serious adverse events | Placebo (Randomized-withdrawal Period) | 0 | 134 |
| Total, serious adverse events | SPD489 (Randomized-withdrawal Period) | 2 | 136 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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.
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