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CompletedNCT02195167

Safety study of Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily in ADHD

This study is completed in the United States. It is testing Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily for ADHD.

ADHDDrugFrom 6 Years to 17 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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United States · 12 sites
  • Woodland International Research Group
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • MCB Clinical Research Centers, LLC
    Colorado Springs, Colorado
    Site status: Not listed — confirm with the team
  • Palm Springs Research Institute
    Hialeah, Florida
    Site status: Not listed — confirm with the team
  • Atlanta Center for Medical Research
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • iResearch Atlanta, LLC
    Decatur, Georgia
    Site status: Not listed — confirm with the team
  • Louisiana Research Associates, Inc
    New Orleans, Louisiana
    Site status: Not listed — confirm with the team
  • Wake Research
    Raleigh, North Carolina
    Site status: Not listed — confirm with the team
  • IPS Research Company
    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
  • Clinical Trials of Texas, Inc. (CTT)
    San Antonio, Texas
    Site status: Not listed — confirm with the team
  • Road Runner Research
    San Antonio, Texas
    Site status: Not listed — confirm with the team
  • Aspen Clinical Research
    Orem, Utah
    Site status: Not listed — confirm with the team
In plain English

Key information made simple

What is this study testing?

This study is testing whether Single Oral Doses of SEP-225289 may be useful for children experiencing ADHD.

What would participation involve?

Participants may receive Single Oral Doses of SEP-225289, attend study visits with the research team. 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 a comparison group, how many visits or travel steps are needed, what role parents or guardians have in the process.

What to expect

Your next step

Study sites are listed in the registry. Recruitment status can differ between sites. Ask the research team to confirm the location, any in-person visits, time commitment, costs or compensation, and participation criteria.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateJuly 2014
Recruitment status
Completed
Enrollment listed in the registry
105
Sponsor
Sumitomo Pharma America, Inc.
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 1Usually an early study focused on safety, tolerability, dosage, and side effects.
Locations
United States
Age range
From 6 Years to 17 Years
Official registry ID
NCT02195167
Official title
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Evaluation of Single Oral Doses of SEP-225289 in Subjects 6 to 17 Years of Age With Attention Deficit Hyperactivity Disorder
Official source
Official registry link

Ask HopeStage to help me review this study

This record does not confirm open recruitment. We can help you understand it and explore other studies.

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Study ID: NCT02195167. We help you review the study, but cannot decide medical eligibility.
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 Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily. Phase 1 studies usually focus mainly on safety, tolerability, dosage, and side effects. They often involve healthy volunteers, but not always. Some Phase 1 studies include people living with the target condition.

Who might this study be for?

This study may concern people with adhd; age range: From 6 Years to 17 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 Sumitomo Pharma America, Inc., which appears to be a pharmaceutical company. 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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