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CompletedNCT01718509

Safety study of Efficacy, Safety, and Tolerability of SPD489 in Binge Eating disorders

This study is completed in the United States and in Germany. It is testing Efficacy, Safety, and Tolerability of SPD489 for Binge Eating disorders.

Eating disorders, Binge Eating disordersDrugFrom 18 Years to 55 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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In plain English

Key information made simple

What is this study testing?

This study is testing whether SPD489 (Lisdexamfetamine dimesylate) may be useful for adults experiencing eating disorders.

What would participation involve?

Participants may receive SPD489 (Lisdexamfetamine dimesylate), attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Germany and in the United States.

Who is it mainly for?

This study appears to be mainly for adults with eating disorders.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)

  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: November 26, 2012
Recruitment status
Completed
Enrollment listed in the registry
390
Sponsor
Shire
Sponsor type
Unknown or unclear
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Germany
Age range
From 18 Years to 55 Years
Official registry ID
NCT01718509
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

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Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Germany · 3 sites
  • Klinische Forschung Berlin-Mitte GmbH
    Berlin
    Site status: Not listed — confirm with the team
  • Klinische Forschung Berlin Buch GmbH
    Berlin
    Site status: Not listed — confirm with the team
  • Klinische Forschung Schwerin GmbH
    Schwerin
    Site status: Not listed — confirm with the team
United States · 45 sites
  • Radiant Research, Inc.
    Tucson, Arizona
    Site status: Not listed — confirm with the team
  • Southern California Research, LLC
    Beverly Hills, California
    Site status: Not listed — confirm with the team
  • Scripps Clinical Research Services
    La Jolla, California
    Site status: Not listed — confirm with the team
  • Pharmacology Research Institute
    Newport Beach, California
    Site status: Not listed — confirm with the team
  • Excel Research, Inc.
    Oceanside, California
    Site status: Not listed — confirm with the team
  • PCSD - Feighner Research
    San Diego, California
    Site status: Not listed — confirm with the team
  • Radiant Research, Inc.
    Denver, Colorado
    Site status: Not listed — confirm with the team
  • Florida Clinical Research Center, LLC
    Bradenton, Florida
    Site status: Not listed — confirm with the team
  • Florida Clinical Research Center, LLC
    Maitland, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc.
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • Miami Research Associates
    South Miami, Florida
    Site status: Not listed — confirm with the team
  • NeuroTrials Research, Inc.
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Capstone Clinical Research
    Libertyville, Illinois
    Site status: Not listed — confirm with the team
  • American Medical Research
    Oak Brook, Illinois
    Site status: Not listed — confirm with the team
  • Deaconess Clinic Gateway Health Center
    Newburgh, Indiana
    Site status: Not listed — confirm with the team
  • Clinical Trials Technology, Inc.
    Prairie Village, Kansas
    Site status: Not listed — confirm with the team
  • Louisiana Research Associates, Inc.
    New Orleans, Louisiana
    Site status: Not listed — confirm with the team
  • Potomac Grove Clinical Research Center
    Gaithersburg, Maryland
    Site status: Not listed — confirm with the team
  • Boston Clinical Trials
    Boston, Massachusetts
    Site status: Not listed — confirm with the team
  • Activmed Practices and Research
    Haverhill, Massachusetts
    Site status: Not listed — confirm with the team
  • Adams Clinical Trials, LLC
    Watertown, Massachusetts
    Site status: Not listed — confirm with the team
  • Rochester Center for Behavioral Medicine
    Rochester Hills, Michigan
    Site status: Not listed — confirm with the team
  • UMN Medical School, Dept of Psychiatry
    Minneapolis, Minnesota
    Site status: Not listed — confirm with the team
  • Scientella, LLA
    St Louis, Missouri
    Site status: Not listed — confirm with the team
  • Robert Lynn Horne, MD, LTD
    Las Vegas, Nevada
    Site status: Not listed — confirm with the team
  • Global Medical Inst LLC; Princeton Medical Institute
    Princeton, New Jersey
    Site status: Not listed — confirm with the team
  • Bioscience Research, LLC
    Mount Kisco, New York
    Site status: Not listed — confirm with the team
  • CNS Clinica at the Brain Resource Center
    New York, New York
    Site status: Not listed — confirm with the team
  • Radiant Research, Inc.
    Akron, Ohio
    Site status: Not listed — confirm with the team
  • Patient Priority Clinical Sites, LLC
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • The Craig and Frances Lindner Center of Hope
    Mason, Ohio
    Site status: Not listed — confirm with the team
  • Clinical Trials of America, Inc.
    Eugene, Oregon
    Site status: Not listed — confirm with the team
  • Sunstone Medical Research, LLC
    Medford, Oregon
    Site status: Not listed — confirm with the team
  • Oregon Center for Clinical Investigators (OCCI, Inc)
    Portland, Oregon
    Site status: Not listed — confirm with the team
  • Lehigh Center for Clinical Research
    Allentown, Pennsylvania
    Site status: Not listed — confirm with the team
  • CRI Lifetree
    Philadelphia, Pennsylvania
    Site status: Not listed — confirm with the team
  • Omega Medical Reserach
    Warwick, Rhode Island
    Site status: Not listed — confirm with the team
  • Radiant Research, Inc.
    Greer, South Carolina
    Site status: Not listed — confirm with the team
  • Clinical Research Associates, Inc.
    Nashville, Tennessee
    Site status: Not listed — confirm with the team
  • Texas Center for Drug Development, Inc.
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Psychiatric Medical Associates
    Plano, Texas
    Site status: Not listed — confirm with the team
  • Radiant Research, Inc.
    San Antonio, Texas
    Site status: Not listed — confirm with the team
  • Advanced Research Institute
    Ogden, Utah
    Site status: Not listed — confirm with the team
  • NeuroScience, Inc.
    Herndon, Virginia
    Site status: Not listed — confirm with the team
  • Summit Research Network (Seattle), LLC
    Seattle, Washington
    Site status: Not listed — confirm with the team
In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with eating disorders. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving SPD489 (Lisdexamfetamine dimesylate), Placebo. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.

Who might this study be for?

This study may concern people with eating disorders; age range: From 18 Years to 55 Years. The criteria appear fairly broad, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Shire, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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