Trial · NCT01291173
Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
NCT01291173, Phase 2, Completed, Shire; results first posted 2012-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder. Trials, record NCT01291173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01291173
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder
- NCT number
- NCT01291173
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 271 participants, actual
- Lead sponsor
- Shire
- Conditions
- Binge Eating Disorder
- Interventions
- lisdexamfetamine dimesylate (SPD489), lisdexamfetamine dimesylate (SPD489), lisdexamfetamine dimesylate (SPD489), Placebo
- First posted
- 2011-02-08
- Last updated
- 2021-06-10
- Results first posted
- 2012-12-31
- Limitations and caveats
External investigation at a site was initiated for reasons unrelated to the study. Lacking information on the investigation, it was deemed prudent to exclude data from subjects enrolled at site (n=11) from the primary analyses of efficacy and safety.
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Log Transformed Binge Days Per Week at Week 11 | Baseline and week 11 | Binge day is defined as a day during which at least 1 binge episode occurs. |
| Secondary | Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks | Baseline and up to 11 weeks | The number of binge episodes per week as assessed by clinical interview based on subject diary. |
| Secondary | 1-Week Binge Response, Last Observation Carried Forward (LOCF) | Last 7 days on study | The 1-week binge response was defined as either a 1-week remission (a 100% reduction of binge episodes from baseline \[ie, a cessation of binge eating behavior\]), or a marked response (75 to \<100% reduction in binge episodes from baseline), or a moderate response (50 to \<75% reduction in binge episodes from baseline), or a negative/minimal response (\<50% reduction in binge episodes from baseline). The 1-week response was determined at the end of the study utilizing a LOCF approach. |
| Secondary | 4-Week Binge Response | Last 28 days on study | Subjects are free from binge episodes for 4 weeks. |
| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Baseline | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) |
| Secondary | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks | up to 11 weeks | CGI-S assesses the severity of the subject's condition on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill) |
| Secondary | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks | Up to 11 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 | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11 | Baseline and week 11 | The YBOCS-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. A score of 0-7 is sub-clinical; 8-15 is mild; 16-23 is moderate; 24-31 is severe; and 32-40 is extreme. |
| Secondary | Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11 | Baseline and week 11 | MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. |
| Secondary | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11 | Baseline and week 11 | The HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity, and 25-30 moderate to severe, and 31-56 severe anxiety. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 Log Transformed Binge Days Per Week at Week 11 | Baseline and week 11 | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Log days | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks | Baseline and up to 11 weeks | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Binge Episodes | MEAN |
| SECONDARY | 1-Week Binge Response, Last Observation Carried Forward (LOCF) | Last 7 days on study | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Participants | NUMBER |
| SECONDARY | 4-Week Binge Response | Last 28 days on study | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | Participants | NUMBER |
| SECONDARY | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline | Baseline | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.) | Percentage of participants | NUMBER |
| SECONDARY | Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Up to 11 Weeks | up to 11 weeks | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.) | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) at Up to 11 Weeks | Up to 11 weeks | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. (Not all subjects in the FAS had an assessment for this outcome.) | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (YBOCS-BE) Total Score at Week 11 | Baseline and week 11 | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Score at Week 11 | Baseline and week 11 | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Week 11 | Baseline and week 11 | Full Analysis Set defined as all subjects who had taken at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group128
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 Log Transformed Binge Days Per Week at Week 11 | Placebo | -1.23 | Standard Error 0.069 | Log days | |
| Change From Baseline in Log Transformed Binge Days Per Week at Week 11 | Lisdexamfetamine Dimesylate (SPD489) 30 mg | -1.24 | Standard Error 0.067 | Log days | |
| Change From Baseline in Log Transformed Binge Days Per Week at Week 11 | Lisdexamfetamine Dimesylate (SPD489) 50 mg | -1.49 | Standard Error 0.066 | Log days | |
| Change From Baseline in Log Transformed Binge Days Per Week at Week 11 | Lisdexamfetamine Dimesylate (SPD489) 70 mg | -1.57 | Standard Error 0.067 | Log days | |
| Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks | Placebo | -4.07 | Standard Deviation 2.718 | Binge Episodes | |
| Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks | Lisdexamfetamine Dimesylate (SPD489) 30 mg | -4.57 | Standard Deviation 3.266 | Binge Episodes | |
| Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks | Lisdexamfetamine Dimesylate (SPD489) 50 mg | -5.10 | Standard Deviation 3.026 | Binge Episodes | |
| Change From Baseline in the Number of Binge Episodes Per Week at Up to 11 Weeks | Lisdexamfetamine Dimesylate (SPD489) 70 mg | -5.09 | Standard Deviation 2.586 | Binge Episodes | |
| 1-Week Binge Response, Last Observation Carried Forward (LOCF) | Placebo | 1 week remission | 23 | Participants | |
| 1-Week Binge Response, Last Observation Carried Forward (LOCF) | Lisdexamfetamine Dimesylate (SPD489) 30 mg | 1 week remission | 28 | Participants |
1 to 10 of 128Source ClinicalTrials.gov
See all 128 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 64 | |
| Overall Study | STARTED | Lisdexamfetamine Dimesylate (SPD489) 30 mg | 66 | |
| Overall Study | STARTED | Lisdexamfetamine Dimesylate (SPD489) 50 mg | 65 | |
| Overall Study | STARTED | Lisdexamfetamine Dimesylate (SPD489) 70 mg | 65 | |
| Overall Study | COMPLETED | Placebo | 47 | |
| Overall Study | COMPLETED | Lisdexamfetamine Dimesylate (SPD489) 30 mg | 51 | |
| Overall Study | COMPLETED | Lisdexamfetamine Dimesylate (SPD489) 50 mg | 52 | |
| Overall Study | COMPLETED | Lisdexamfetamine Dimesylate (SPD489) 70 mg | 52 | |
| Overall Study | NOT COMPLETED | Placebo | 17 | |
| Overall Study | NOT COMPLETED | Lisdexamfetamine Dimesylate (SPD489) 30 mg | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events120
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 | Placebo | 5 | 63 | |
| other | Dry mouth | Gastrointestinal disorders | Lisdexamfetamine Dimesylate (SPD489) 30 mg | 22 | 66 | |
| other | Dry mouth | Gastrointestinal disorders | Lisdexamfetamine Dimesylate (SPD489) 50 mg | 22 | 65 | |
| other | Dry mouth | Gastrointestinal disorders | Lisdexamfetamine Dimesylate (SPD489) 70 mg | 27 | 65 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Placebo | 4 | 63 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Lisdexamfetamine Dimesylate (SPD489) 30 mg | 17 | 66 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Lisdexamfetamine Dimesylate (SPD489) 50 mg | 13 | 65 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Lisdexamfetamine Dimesylate (SPD489) 70 mg | 12 | 65 | |
| other | Insomnia | Psychiatric disorders | Placebo | 1 | 63 | |
| other | Insomnia | Psychiatric disorders | Lisdexamfetamine Dimesylate (SPD489) 30 mg | 7 | 66 |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Lisdexamfetamine Dimesylate (SPD489) 30 mg | ||
| Total, all-cause mortality | Lisdexamfetamine Dimesylate (SPD489) 50 mg | ||
| Total, all-cause mortality | Lisdexamfetamine Dimesylate (SPD489) 70 mg | ||
| Total, other adverse events | Placebo | 37 | 63 |
| Total, other adverse events | Lisdexamfetamine Dimesylate (SPD489) 30 mg | 57 | 66 |
| Total, other adverse events | Lisdexamfetamine Dimesylate (SPD489) 50 mg | 56 | 65 |
| Total, other adverse events | Lisdexamfetamine Dimesylate (SPD489) 70 mg | 53 | 65 |
| Total, serious adverse events | Placebo | 0 | 63 |
| Total, serious adverse events | Lisdexamfetamine Dimesylate (SPD489) 30 mg | 2 | 66 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25587645 | DERIVED |
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.
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