Trial · NCT01718483

SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

NCT01718483, Phase 3, Completed, Shire; results first posted 2014-07-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder. Trials, record NCT01718483. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01718483

On this page

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: NCT01718483
Status: Completed
Phases: Phase 3
Enrollment: 383 participants, actual
Lead sponsor: Shire
Conditions: Binge Eating Disorder
Interventions: SPD489 (Lisdexamfetamine dimesylate), Placebo
First posted: 2012-10-31
Last updated: 2021-06-08
Other registries' IDs: eudract:2012-003309-91
Results first posted: 2014-07-21

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 (Weeks 11-12)	Baseline and Visit 8 (Weeks 11-12)	Binge days defined as days during which at least 1 binge episode occurred. As assessed by clinical interview based on participant binge diary.
Secondary	Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Up to 12 weeks	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	Percentage 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 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 Week 12/Early termination (ET)
Secondary	Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks	Baseline and Week 12/ET
Secondary	Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks	Baseline and Week 12/ET
Secondary	Binge Eating Response	Week 12/ET	Response is based on the reduction in the number of binge eating episodes. Percentage of participants with response was reported. 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 (Weeks 11-12)	Baseline and Visit 8 (Weeks 11-12)

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

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 (Weeks 11-12)	Baseline and Visit 8 (Weeks 11-12)	The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).	Binge days per week	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	Up to 12 weeks	The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With a 4-Week Cessation From Binge Eating	Up to 12 weeks	The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).	percentage of participants	NUMBER
SECONDARY	Percent Change From Baseline in Body Weight at Week 12	Baseline and Week 12	The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).	percent 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	The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks	Baseline and Week 12/Early termination (ET)	The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.	millimole per liter (mmol/L)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks	Baseline and Week 12/ET	The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants 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 Week 12/ET	The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.	Percent hemoglobin	LEAST_SQUARES_MEAN
SECONDARY	Binge Eating Response	Week 12/ET	The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week). Not all participants had data for this outcome.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 (Weeks 11-12)	Baseline and Visit 8 (Weeks 11-12)	The Full Analysis Set was defined as all randomized participants who took at least 1 dose of investigational product and who had 1 post-baseline primary efficacy assessment (number of binge days per week calculated for at least 1 week).	Binge episodes per week	LEAST_SQUARES_MEAN

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group92

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)	PLACEBO	-2.51	Standard Error 0.125	Binge days per week
Change From Baseline in the Number of Binge Days Per Week at Visit 8 (Weeks 11-12)	SPD489	-3.87	Standard Error 0.124	Binge days per week
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	PLACEBO	47.3	95% Confidence Interval 40.1 to 54.5	percentage of participants
Percentage of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	SPD489	82.1	95% Confidence Interval 76.7 to 87.6	percentage of participants
Percentage of Participants With a 4-Week Cessation From Binge Eating	PLACEBO	14.1	95% Confidence Interval 9.1 to 19.2	percentage of participants
Percentage of Participants With a 4-Week Cessation From Binge Eating	SPD489	40.0	95% Confidence Interval 33.0 to 47.0	percentage of participants
Percent Change From Baseline in Body Weight at Week 12	PLACEBO	0.11	Standard Error 0.295	percent change
Percent Change From Baseline in Body Weight at Week 12	SPD489	-6.25	Standard Error 0.292	percent change
Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12	PLACEBO	-8.28	Standard Error 0.550	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	-15.68	Standard Error 0.546	units on a scale

1 to 10 of 92Source ClinicalTrials.gov

See all 92 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	PLACEBO	191
Overall Study	STARTED	SPD489	192
Overall Study	Treated	PLACEBO	187
Overall Study	Treated	SPD489	192
Overall Study	COMPLETED	PLACEBO	157
Overall Study	COMPLETED	SPD489	158
Overall Study	NOT COMPLETED	PLACEBO	34
Overall Study	NOT COMPLETED	SPD489	34

Source ClinicalTrials.gov

Adverse events34

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	4	187	4
other	Constipation	Gastrointestinal disorders	SPD489	11	192	11
other	Dry mouth	Gastrointestinal disorders	PLACEBO	16	187	19
other	Dry mouth	Gastrointestinal disorders	SPD489	76	192	86
other	Nausea	Gastrointestinal disorders	PLACEBO	14	187	15
other	Nausea	Gastrointestinal disorders	SPD489	16	192	19
other	Fatigue	General disorders	PLACEBO	10	187	11
other	Fatigue	General disorders	SPD489	7	192	7
other	Feeling jittery	General disorders	PLACEBO	2	187	3
other	Feeling jittery	General disorders	SPD489	11	192	13

1 to 10 of 34Source ClinicalTrials.gov

See all 34 adverse events

Adverse 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	67	187
Total, other adverse events	SPD489	125	192
Total, serious adverse events	PLACEBO	2	187
Total, serious adverse events	SPD489	3	192

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
26346638	RESULT	PubMed
29497297	DERIVED	PubMed
30013816	DERIVED	PubMed
30817099	DERIVED	PubMed
32237290	DERIVED	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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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