MedTrace Logo

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

NCT01718483 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2021-06-08

Study results available
· View outcomes & findings →

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

Conditions

  • Binge Eating Disorder

Interventions

DRUG

SPD489 (Lisdexamfetamine dimesylate)

50 or 70 mg administered orally, once-daily for up to 12 weeks

DRUG

Placebo

Administered once-daily, orally, for up to 12 weeks

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-11-26
Primary Completion
2013-09-25
Completion
2013-09-25

Countries

  • United States
  • Germany
  • Spain
  • Sweden

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 NCT01718483 on ClinicalTrials.gov