Phase 3 N=390 Randomized Double-blind Treatment

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

Binge Eating Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01718509 ↗

Enrolled (actual)

390

Serious AEs

0.8%

Results posted

Aug 2014

Primary outcome: Primary: Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12 — -2.26; -3.92 Binge days per week — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: SPD489 (Lisdexamfetamine dimesylate) (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Shire
Primary completion: Sep 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in the Number of Binge Days Per Week at Visit 8 Which Spans Weeks 11/12	-2.26; -3.92	<0.001 sig
SECONDARY Percent of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores	42.9; 86.2	<0.001 sig
SECONDARY Percent of Participants With a 4-Week Cessation From Binge Eating	13.1; 36.2	<0.001 sig
SECONDARY Percent Change From Baseline in Body Weight (kg) at Week 12	-0.15; -5.57	<0.001 sig
SECONDARY Change From Baseline in Yale-Brown Obsessive Compulsive Scale Modified for Binge Eating (Y-BOCS-BE) Total Score at Week 12	-7.42; -15.36	<0.001 sig
SECONDARY Change From Baseline in Fasting Triglyceride Levels at Up to 12 Weeks	0.062; -0.133	0.002 sig
SECONDARY Change From Baseline In Fasting Total Cholesterol Levels at Up to 12 Weeks	-0.126; -0.204	0.234
SECONDARY Change From Baseline in Hemoglobin A1c Levels at Up to 12 Weeks	-0.02; 0.01	0.185
SECONDARY Binge Eating Response	23.9; 55.9; 13.4; 22.8; 19.7; 16.6	<0.001 sig
SECONDARY Change From Baseline in the Number of Binge Episodes Per Week at Visit 8 Which Spans Weeks 11/12	-3.31; -5.54	<0.001 sig
SECONDARY Change From Baseline in Eating Inventory Scores at Week 12	2.44; 3.71; -2.01; -5.61; -1.93; -6.14	0.011 sig
SECONDARY Change From Baseline in Binge Eating Scale (BES) Score at Week 12	-8.24; -17.52	<0.001 sig
SECONDARY Change From Baseline in Frontal Systems Behavior (FrSBe) Total Score at Up to 12 Weeks	-3.09; -4.05	0.298
SECONDARY EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Mobility	86.9; 91.7; 8.9; 7.1; 3.0; 0.6	—
SECONDARY EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Self-Care	97.0; 97.0; 2.4; 3.0; 0.6; 0	—
SECONDARY EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Usual Activities	82.1; 89.9; 14.3; 8.3; 3.0; 1.2	—
SECONDARY EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Pain/Discomfort	75.6; 76.3; 18.5; 20.1; 3.0; 3.0	—
SECONDARY EuroQoL Group 5-Dimension 5-Level Self-Report (EQ-5D-5L): Anxiety/Depression	69.6; 76.3; 23.2; 20.7; 4.8; 2.4	—
SECONDARY Columbia-Suicide Severity Rating Scale (C-SSRS)	0; 0; 0; 0	—
SECONDARY Change in Amphetamine Cessation Symptom Assessment (ACSA) Total Score From Baseline to Week 12.	7.0; 4.6	—

Summary

The primary objective of the study is to demonstrate the efficacy of SPD489 compared with placebo in adults (18 55 years of age inclusive) with moderate to severe Binge Eating Disorder at Visit 8 (Weeks 11 and 12) as measured by the number of binge days (defined as days during which at least 1 binge episode occurs) per week as assessed by clinical interview based on subject diary

Eligibility Criteria

Inclusion Criteria

The subject cannot be enrolled in the study before all of the following inclusion criteria (including test results) are met:

Subject is between 18-55 years of age.
Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED:
Subject has a BED diagnosis.
Subject's BED is of at least moderate severity with subjects reporting at least 3 binge eating days per week.
Female subjects must have a negative serum B-HCG pregnancy test and a negative urine pregnancy test and agree to comply with any applicable contraceptive requirements.

Exclusion Criteria

Subjects are excluded from the study if any of the following exclusion criteria are met:

Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
Subject is receiving psychotherapy (eg, supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss support (eg, Weight Watchers) for BED.
Subject has used psychostimulants to facilitate fasting or dieting as a part of their BED.
Subject has a lifetime history of psychosis, mania, hypomania, dementia, or ADHD.
Subject is considered a suicide risk, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems.
Subject has a history of moderate or severe hypertension.
Subject is female and pregnant or nursing.
Subject has had bariatric surgery, lap bands, duodenal stents, or other procedures for weight loss.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01718509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.