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Study identifier: NCT01657019 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

Open Label Extension in Adults With Binge Eating Disorder (BED)

Condition: Binge Eating Disorder  ·  Sponsor: Shire

PhasePhase 3
Planned participants604
Who can joinAll sexes, 18 Years to 55 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where89 locations · 3 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

To evaluate the safety and tolerability of SPD489 administered as a daily morning dose (50 or 70mg) in the treatment of moderate to severe binge eating disorder (BED) in adults

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion criteria: 1. Completion of an antecedent SPD489 BED Double-blind Study 2. Subject meets the following Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for a diagnosis of BED 3. Subject has a body mass index (BMI) of \> or =18 and \< or =45 Exclusion criteria: 1. Subject has concurrent symptoms of bulimia nervosa or anorexia nervosa. 2. Subject is considered a suicide risk or risk to harm others

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (89)

Birmingham Research GroupBirmingham, Alabama, United States
Radiant ResearchTucson, Arizona, United States
Clinical Study Centers, LLCLittle Rock, Arkansas, United States
Southwestern Research, Inc.Beverly Hills, California, United States
TRIMED Clinical TrialsCorona, California, United States
Pharmacology Research InstituteEncino, California, United States
Scripps Clinical Research ServicesLa Jolla, California, United States
Pharmacology Research InstituteLos Alamitos, California, United States
Pharmacology Research InstituteNewport Beach, California, United States
Pacific Research Partners, LLCOakland, California, United States
Excell Research, IncOceanside, California, United States
PCSD - Feighner ResearchSan Diego, California, United States

+ 77 more locations — full list on the registry record.

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