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Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder (BED)

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Shire

Status and phase

Completed
Phase 2

Conditions

Binge Eating Disorder

Treatments

Drug: lisdexamfetamine dimesylate (SPD489)
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01291173
SPD489-208

Details and patient eligibility

About

To evaluate the efficacy of SPD489 compared to placebo in the treatment of moderate to severe binge eating disorder as measured by the number of binge days per week

Enrollment

271 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

  • Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of binge eating disorder (BED).
  • Binge eating disorder is of at least moderate severity in which subjects report at least 3 binge eating days per week.
  • Subject has a body mass index (BMI) of >24 and <46.

Exclusion

  • Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa.
  • Subject is considered a suicide risk or risk to harm others.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

271 participants in 4 patient groups, including a placebo group

SPD489 30 mg
Experimental group
Treatment:
Drug: lisdexamfetamine dimesylate (SPD489)
Drug: lisdexamfetamine dimesylate (SPD489)
Drug: lisdexamfetamine dimesylate (SPD489)
SPD489 50 mg
Experimental group
Treatment:
Drug: lisdexamfetamine dimesylate (SPD489)
Drug: lisdexamfetamine dimesylate (SPD489)
Drug: lisdexamfetamine dimesylate (SPD489)
SPD489 70 mg
Experimental group
Treatment:
Drug: lisdexamfetamine dimesylate (SPD489)
Drug: lisdexamfetamine dimesylate (SPD489)
Drug: lisdexamfetamine dimesylate (SPD489)
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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