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CompletedNCT03260205

Safety study of SPD489 Compared With Placebo in ADHD

This study is completed in the United States. It is testing SPD489 Compared With Placebo for ADHD.

ADHDDrugFrom 4 Years to 5 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 Compared With Placebo may be useful for children experiencing ADHD.

What would participation involve?

Participants may receive SPD489 Compared With Placebo, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in the United States.

Who is it mainly for?

This study appears to be mainly for children with ADHD. Because it involves minors, a parent or guardian may need to be involved.

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, what role parents or guardians have in the process.

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: September 6, 2017
Recruitment status
Completed
Enrollment listed in the registry
199
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
Age range
From 4 Years to 5 Years
Official registry ID
NCT03260205
Official title
A Phase 3, Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled, Fixed-Dose Safety and Efficacy Study of SPD489 Compared With Placebo in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity 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.

United States · 48 sites
  • Harmonex, Inc
    Dothan, Alabama
    Site status: Not listed — confirm with the team
  • Preferred Research Partners, Inc
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • CMB Clinical Trials
    Colton, California
    Site status: Not listed — confirm with the team
  • Sun Valley Research Center
    Imperial, California
    Site status: Not listed — confirm with the team
  • Alliance for Wellness d/b/a Alliance for Research
    Long Beach, California
    Site status: Not listed — confirm with the team
  • Asclepes Research
    Panorama City, California
    Site status: Not listed — confirm with the team
  • Psychiatric Centers at San Diego
    San Diego, California
    Site status: Not listed — confirm with the team
  • UCSF Dept of Psychiatry
    San Francisco, California
    Site status: Not listed — confirm with the team
  • Elite Clinical Trials, Inc
    Wildomar, California
    Site status: Not listed — confirm with the team
  • Avail Clinical Research, LLC
    DeLand, Florida
    Site status: Not listed — confirm with the team
  • Sarkis Clinical Trials
    Gainesville, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc.
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • Medical Research Group of Central Florida
    Orange City, Florida
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • APG Research, LLC
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • University of South Florida
    St. Petersburg, Florida
    Site status: Not listed — confirm with the team
  • University of South Florida Department Of Psychiatry
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • iResearch Atlanta LLC
    Decatur, Georgia
    Site status: Not listed — confirm with the team
  • Lake Charles Clinical Trials
    Lake Charles, Louisiana
    Site status: Not listed — confirm with the team
  • Kennedy Krieger Institute
    Baltimore, Maryland
    Site status: Not listed — confirm with the team
  • Rochester Center for Behavioral Medicine
    Rochester Hills, Michigan
    Site status: Not listed — confirm with the team
  • Clinical Neurophysiology Services
    Sterling Heights, Michigan
    Site status: Not listed — confirm with the team
  • Washington University
    St Louis, Missouri
    Site status: Not listed — confirm with the team
  • Premier Psychiatric Reseach Institute, LLC
    Lincoln, Nebraska
    Site status: Not listed — confirm with the team
  • Jersey Shore University Medical Center (JSUMC)
    Neptune City, New Jersey
    Site status: Not listed — confirm with the team
  • Manhattan Behavioral Medicine
    New York, New York
    Site status: Not listed — confirm with the team
  • University of Rochester
    Rochester, New York
    Site status: Not listed — confirm with the team
  • University Hospitals Case Medical Center
    Cleveland, Ohio
    Site status: Not listed — confirm with the team
  • Pediatric Associates of Fairfield, Inc
    Fairfield, Ohio
    Site status: Not listed — confirm with the team
  • IPS Research Company
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Oklahoma Clinical Research Center
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Paradigm Research Professionals
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Cutting Edge Research Group
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Cyn3rgy Research Center
    Gresham, Oregon
    Site status: Not listed — confirm with the team
  • Rainbow Research Inc
    Barnwell, South Carolina
    Site status: Not listed — confirm with the team
  • Carolina Clinical Trials, Inc.
    Charleston, South Carolina
    Site status: Not listed — confirm with the team
  • Coastal Carolina Research
    Mt. Pleasant, South Carolina
    Site status: Not listed — confirm with the team
  • Clinical Neuroscience Solutions, Inc
    Memphis, Tennessee
    Site status: Not listed — confirm with the team
  • BioBehavioral Research of Austin
    Austin, Texas
    Site status: Not listed — confirm with the team
  • Bayou City Research Limited
    Houston, Texas
    Site status: Not listed — confirm with the team
  • BI Research Center
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Red Oak Psychiatry Associates
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Road Runner Research
    San Antonio, Texas
    Site status: Not listed — confirm with the team
  • Family Psychiatry of the Woodlands
    The Woodlands, Texas
    Site status: Not listed — confirm with the team
  • Ericksen Research and Development
    Clinton, Utah
    Site status: Not listed — confirm with the team
  • Clinical Research Partners, LLC
    Petersburg, Virginia
    Site status: Not listed — confirm with the team
  • Northwest Clinical Research Center
    Bellevue, Washington
    Site status: Not listed — confirm with the team
  • Seattle Childrens Hospital, Pearl Clinic
    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 adhd. 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 Placebo, SPD489 (Lisdexamfetamine dimesylate), SPD489. 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 adhd; age range: From 4 Years to 5 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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