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

NCT01291173 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 271

Last updated 2021-06-10

Study results available
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Summary

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

Conditions

  • Binge Eating Disorder

Interventions

DRUG

lisdexamfetamine dimesylate (SPD489)

SPD489-30mg capsules taken once daily for up to 11 weeks

DRUG

lisdexamfetamine dimesylate (SPD489)

SPD489 50mg capsules taken once-daily for up to 11 weeks

DRUG

lisdexamfetamine dimesylate (SPD489)

SPD489 70mg capsule taken once-daily for up to 11 weeks

DRUG

Placebo

Placebo capsule taken once daily for up to 11 weeks

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-10
Primary Completion
2012-01-30
Completion
2012-01-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01291173 on ClinicalTrials.gov