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NCT06431256RECRUITINGIRB Ready

Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years with ADHD

Sponsored by Ironshore Pharmaceuticals and Development, Inc

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 168 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This study will evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD.

Who Can Participate

Inclusion Criteria

The subject's assigned caregiver must be able to read, write, and/or understand at a level sufficient to provide informed consent and will provide this written consent (and subject will provide assent, if required by the IRB) before any study-specific activity is performed. 2. Subjects must be male or female children 4 to 5 years of age at the time of consent and assent (if applicable). 3. Subjects must have a diagnosis of ADHD as defined by the DSM-5 criteria with confirmation using the Mini - International Neuropsychiatric Interview for Children and Adolescents (MINI KID). 4. All subjects must have an ADHD-RS-IV Preschool Version Parent Total Score of โ‰ฅ28 for boys or โ‰ฅ24 for girls at Baseline (Visit 2). In addition, subjects not receiving pharmacotherapy for ADHD at time of consent must have an ADHD-RS-IV Preschool Version Parent Total Score of โ‰ฅ28 for boys or โ‰ฅ24 for girls at Screening; if the ADHD-RS-IV total score at Screening differs from the score at Base

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

168 participants

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Age Range

4 Years - 5 Years

โšง

Gender

ALL

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Sponsor

Ironshore Pharmaceuticals and Development, Inc

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Dothan

Alabama

Location available
View Dothan location page
Unknown

Anaheim

California

Location available
View Anaheim location page
Unknown

Jacksonville

Florida

Location available
View Jacksonville location page
Unknown

Miami Springs

Florida

Location available
View Miami Springs location page
Unknown

Orlando

Florida

Location available
View Orlando location page
Unknown

Decatur

Georgia

Location available
View Decatur location page
Unknown

New Orleans

Louisiana

Location available
View New Orleans location page
Unknown

Saint Charles

Missouri

Location available
View Saint Charles location page
Unknown

Lincoln

Nebraska

Location available
View Lincoln location page

๐Ÿ“ And 4 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for ADHD Treatment in Dothan?

Join others in Alabama exploring innovative treatment options through clinical research

ADHD Treatment Options in Dothan, Alabama

If you're searching for ADHD treatment in Dothan, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Dothan, Anaheim, Jacksonville and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with ADHD. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 168 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for ADHD?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for ADHD

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This ADHD Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06431256. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.