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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01718509

Public ClinicalTrials.gov record NCT01718509. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 12:29 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The SPD489-344, Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT01718509
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shire
Industry
Enrollment
390 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 26, 2012 (Actual)
Primary completion
Sep 20, 2013 (Actual)
Completion
Sep 20, 2013 (Actual)
Last update posted
Jul 16, 2021

2012 – 2013

United States locations

U.S. sites
45
U.S. states
27
U.S. cities
45
Facility City State ZIP Site status
Radiant Research, Inc. Tucson Arizona 85710 —
Southern California Research, LLC Beverly Hills California 90210 —
Scripps Clinical Research Services La Jolla California 92037 —
Pharmacology Research Institute Newport Beach California 92660 —
Excel Research, Inc. Oceanside California 92056 —
PCSD - Feighner Research San Diego California 92108 —
Radiant Research, Inc. Denver Colorado 80239 —
Florida Clinical Research Center, LLC Bradenton Florida 34201 —
Florida Clinical Research Center, LLC Maitland Florida 32751 —
Clinical Neuroscience Solutions, Inc. Orlando Florida 32806 —
Miami Research Associates South Miami Florida 33143 —
NeuroTrials Research, Inc. Atlanta Georgia 30342 —
Capstone Clinical Research Libertyville Illinois 60048 —
American Medical Research Oak Brook Illinois 60523 —
Deaconess Clinic Gateway Health Center Newburgh Indiana 47630 —
Clinical Trials Technology, Inc. Prairie Village Kansas 66206 —
Louisiana Research Associates, Inc. New Orleans Louisiana 70114 —
Potomac Grove Clinical Research Center Gaithersburg Maryland 20877 —
Boston Clinical Trials Boston Massachusetts 02131 —
Activmed Practices and Research Haverhill Massachusetts 01830 —
Adams Clinical Trials, LLC Watertown Massachusetts 02472 —
Rochester Center for Behavioral Medicine Rochester Hills Michigan 48307 —
UMN Medical School, Dept of Psychiatry Minneapolis Minnesota 55454 —
Scientella, LLA St Louis Missouri 63141 —
Robert Lynn Horne, MD, LTD Las Vegas Nevada 89102 —
Global Medical Inst LLC; Princeton Medical Institute Princeton New Jersey 08540 —
Bioscience Research, LLC Mount Kisco New York 10549 —
CNS Clinica at the Brain Resource Center New York New York 10023 —
Radiant Research, Inc. Akron Ohio 44311 —
Patient Priority Clinical Sites, LLC Cincinnati Ohio 45215 —
The Craig and Frances Lindner Center of Hope Mason Ohio 45040 —
Clinical Trials of America, Inc. Eugene Oregon 97401 —
Sunstone Medical Research, LLC Medford Oregon 97504 —
Oregon Center for Clinical Investigators (OCCI, Inc) Portland Oregon 97210 —
Lehigh Center for Clinical Research Allentown Pennsylvania 18104 —
CRI Lifetree Philadelphia Pennsylvania 19139 —
Omega Medical Reserach Warwick Rhode Island 02886 —
Radiant Research, Inc. Greer South Carolina 29650 —
Clinical Research Associates, Inc. Nashville Tennessee 37203 —
Texas Center for Drug Development, Inc. Houston Texas 77081 —
Psychiatric Medical Associates Plano Texas 75093 —
Radiant Research, Inc. San Antonio Texas 78229 —
Advanced Research Institute Ogden Utah 84405 —
NeuroScience, Inc. Herndon Virginia 20170 —
Summit Research Network (Seattle), LLC Seattle Washington 98104 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01718509, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 16, 2021 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01718509 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →