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CompletedNCT04895215

Safety study of Efficacy, Safety, and Tolerability of AB-2004 in Autism Spectrum Disorder (ASD)

This study is completed in the United States, in Australia, and in New Zealand. It is testing Efficacy, Safety, and Tolerability of AB-2004 for Autism Spectrum Disorder (ASD).

Anxiety, Autism spectrumDrugFrom 5 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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In plain English

Key information made simple

What is this study testing?

This study is testing whether AB-2004 may be useful for people experiencing anxiety.

What would participation involve?

Participants may receive AB-2004, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Australia, in New Zealand, and in the United States.

Who is it mainly for?

This study appears to be mainly for people with anxiety. Because it may involve 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: August 2, 2021
Recruitment status
Completed
Enrollment listed in the registry
156
Sponsor
Vertero Therapeutics
Sponsor type
Biotech company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 2Usually explores whether the intervention may work, while continuing to monitor safety.
Locations
United States, Australia, New Zealand
Age range
From 5 Years to 17 Years
Official registry ID
NCT04895215
Official title
A Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of AB-2004 in an Autism Spectrum Disorder Population

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.

Australia · 5 sites
  • Brain Mind Centre
    Sydney, New South Wales
    Site status: Not listed — confirm with the team
  • Westmead Children's Hospital
    Sydney, New South Wales
    Site status: Not listed — confirm with the team
  • Children's Health Queensland Hospital
    South Brisbane, Queensland
    Site status: Not listed — confirm with the team
  • Monash Kids Research
    Clayton, Victoria
    Site status: Not listed — confirm with the team
  • Murdoch Children's Research Institute
    Parkville, Victoria
    Site status: Not listed — confirm with the team
New Zealand · 1 site
  • Optimal Clinical Trials
    Grafton, Auckland
    Site status: Not listed — confirm with the team
United States · 18 sites
  • Harmonex Neuroscience Research
    Dothan, Alabama
    Site status: Not listed — confirm with the team
  • Southwestern Autism Research and Resource Center
    Phoenix, Arizona
    Site status: Not listed — confirm with the team
  • University of Arizona
    Tucson, Arizona
    Site status: Not listed — confirm with the team
  • Cortica Marin
    San Rafael, California
    Site status: Not listed — confirm with the team
  • Cortica Westlake
    Westlake Village, California
    Site status: Not listed — confirm with the team
  • IMMUNOe Research Centers
    Centennial, Colorado
    Site status: Not listed — confirm with the team
  • Yale University
    New Haven, Connecticut
    Site status: Not listed — confirm with the team
  • CNS Solutions
    Jacksonville, Florida
    Site status: Not listed — confirm with the team
  • CNS Solutions
    Orlando, Florida
    Site status: Not listed — confirm with the team
  • University of South Florida
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • Baber Research
    Naperville, Illinois
    Site status: Not listed — confirm with the team
  • University of Missouri, Thompson Center for Autism and Neurodevelopmental Disorders
    Columbia, Missouri
    Site status: Not listed — confirm with the team
  • Clinical Research of Southern Nevada
    Las Vegas, Nevada
    Site status: Not listed — confirm with the team
  • Spectrum Neuroscience and Treatment Institute
    New York, New York
    Site status: Not listed — confirm with the team
  • Nathan S. Kline Institute for Psychiatric Research
    Orangeburg, New York
    Site status: Not listed — confirm with the team
  • Ohio State University
    Columbus, Ohio
    Site status: Not listed — confirm with the team
  • Vanderbilt University Medical Center
    Nashville, Tennessee
    Site status: Not listed — confirm with the team
  • Relaro Medical Trials
    Dallas, Texas
    Site status: Not listed — confirm with the team

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Study ID: NCT04895215. 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 anxiety. 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 AB-2004, Placebo. Phase 2 studies usually explore whether the intervention may work, while continuing to monitor safety.

Who might this study be for?

This study may concern people with anxiety; age range: From 5 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 Vertero Therapeutics, which appears to be a biotech 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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