Trial · NCT01718509
SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
NCT01718509, Phase 3, Completed, Shire; results first posted 2014-08-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder. Trials, record NCT01718509. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01718509
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder
- NCT number
- NCT01718509
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 390 participants, actual
- Lead sponsor
- Shire
- Conditions
- Binge Eating Disorder
- Interventions
- SPD489 (Lisdexamfetamine dimesylate), Placebo
- First posted
- 2012-10-31
- Last updated
- 2021-07-16
- Other registries' IDs
- eudract:2012-003310-14
- Results first posted
- 2014-08-21
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 | Baseline and Visit 8 Which Spans Weeks 11/12 | Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on subject binge diary. |
| Secondary | Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | Up to 12 weeks | Clinical Global Impression-Improvement (CGI-I) consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved) or 2 (much improved) on the scale. |
| Secondary | Percent of Participants With a 4-Week Cessation From Binge Eating | Up to 12 weeks | 4-week cessation from binge eating is defined as no binge eating episodes for 28 consecutive days prior to the last study visit. |
| Secondary | Percent Change From Baseline in Body Weight (kg) at Week 12 | Baseline and week 12 | |
| Secondary | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 | Baseline and week 12 | The Y-BOCS-BE measures the obsession of binge-eating thoughts and compulsiveness of binge-eating behaviors. The scale is a clinician-rated, 10-item scale, each item rated from 0 (no symptoms) to 4 (extreme symptoms). Total scores range from 0 to 40. Reduction in total score indicates improvement. |
| Secondary | Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks | Baseline and up to 12 weeks | |
| Secondary | Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks | Baseline and up to 12 weeks | |
| Secondary | Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks | Baseline and up to 12 weeks | |
| Secondary | Binge Eating Response | Up to 12 weeks | Response is based on the reduction in the number of binge eating episodes. Responses were categorized as follows: -1-week Cessation = 100% reduction in binge episodes during the preceding 7 days -Marked Reduction = 99% to 75% reduction during the time since the previous visit -Moderate Reduction = 74% to 50% reduction during the time since the previous visit -Negative to Minimal Reduction = \<50% reduction during the time since the previous visit |
| Secondary | Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12 | Baseline and Visit 8 Which Spans Weeks 11/12 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 | Baseline and Visit 8 Which Spans Weeks 11/12 | The Full Analysis Set was defined as all randomized subjects who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (i.e., number of binge days per week calculated for at least 1 week). | Binge days per week | LEAST_SQUARES_MEAN |
| SECONDARY | Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | Up to 12 weeks | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With a 4-Week Cessation From Binge Eating | Up to 12 weeks | Full Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Body Weight (kg) at Week 12 | Baseline and week 12 | Full Analysis Set. | percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 | Baseline and week 12 | Full Analysis Set. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks | Baseline and up to 12 weeks | Full Analysis Set. Not all subjects had data for this outcome. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks | Baseline and up to 12 weeks | Full Analysis Set. Not all subjects had data for this outcome. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks | Baseline and up to 12 weeks | Full Analysis Set. Not all subjects had data for this outcome. | Percent | LEAST_SQUARES_MEAN |
| SECONDARY | Binge Eating Response | Up to 12 weeks | Full Analysis Set. Not all subjects had data for this outcome. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12 | Baseline and Visit 8 Which Spans Weeks 11/12 | Full Analysis Set. | Binge episodes per week | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 | PLACEBO | -2.26 | Standard Error 0.137 | Binge days per week | |
| Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 | SPD489 | -3.92 | Standard Error 0.135 | Binge days per week | |
| Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | PLACEBO | 42.9 | 95% Confidence Interval 35.5 to 50.2 | percentage of participants | |
| Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores | SPD489 | 86.2 | 95% Confidence Interval 81.1 to 91.3 | percentage of participants | |
| Percent of Participants With a 4-Week Cessation From Binge Eating | PLACEBO | 13.1 | 95% Confidence Interval 8.1 to 18.0 | percentage of participants | |
| Percent of Participants With a 4-Week Cessation From Binge Eating | SPD489 | 36.2 | 95% Confidence Interval 29.1 to 43.3 | percentage of participants | |
| Percent Change From Baseline in Body Weight (kg) at Week 12 | PLACEBO | -0.15 | Standard Error 0.353 | percentage change | |
| Percent Change From Baseline in Body Weight (kg) at Week 12 | SPD489 | -5.57 | Standard Error 0.350 | percentage change | |
| Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 | PLACEBO | -7.42 | Standard Error 0.571 | units on a scale | |
| Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12 | SPD489 | -15.36 | Standard Error 0.563 | units on a scale |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PLACEBO | 195 | |
| Overall Study | STARTED | SPD489 | 195 | |
| Overall Study | COMPLETED | PLACEBO | 147 | |
| Overall Study | COMPLETED | SPD489 | 147 | |
| Overall Study | NOT COMPLETED | PLACEBO | 48 | |
| Overall Study | NOT COMPLETED | SPD489 | 48 |
Source ClinicalTrials.gov
Adverse events28
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 | PLACEBO | 1 | 185 | 1 |
| other | Constipation | Gastrointestinal disorders | SPD489 | 10 | 181 | 10 |
| other | Diarrhoea | Gastrointestinal disorders | PLACEBO | 3 | 185 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | SPD489 | 11 | 181 | 12 |
| other | Dry mouth | Gastrointestinal disorders | PLACEBO | 11 | 185 | 11 |
| other | Dry mouth | Gastrointestinal disorders | SPD489 | 60 | 181 | 60 |
| other | Nausea | Gastrointestinal disorders | PLACEBO | 8 | 185 | 9 |
| other | Nausea | Gastrointestinal disorders | SPD489 | 16 | 181 | 17 |
| other | Fatigue | General disorders | PLACEBO | 9 | 185 | 12 |
| other | Fatigue | General disorders | SPD489 | 17 | 181 | 21 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PLACEBO | ||
| Total, all-cause mortality | SPD489 | ||
| Total, other adverse events | PLACEBO | 43 | 185 |
| Total, other adverse events | SPD489 | 100 | 181 |
| Total, serious adverse events | PLACEBO | 2 | 185 |
| Total, serious adverse events | SPD489 | 1 | 181 |
Source ClinicalTrials.gov
Papers5
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| SPD489 vs PLACEBO: serious adverse events |
Source Trial comparisons
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/NCT01718509
GET https://conductscience.org/api/trials/v1/NCT01718509/results?page=2