Stimulant

Evening Dosed Methylphenidate for ADHD

Anaheim, CA

Phase 3

Recruiting

Research Sponsored by Ironshore Pharmaceuticals and Development, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be male or female children 4 to 5 years of age at the time of consent and assent (if applicable).

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (baseline), day 8, day 15, day 22

Awards & highlights

Pivotal Trial

Summary

This trial will test how well a new medication called HLD200 (at doses of 20 mg and 40 mg) works, if it is safe, and how the body processes it in children

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Who is the study for?

This trial is for children aged 4-5 with ADHD, who have a vocabulary score within the normal range and meet specific criteria for ADHD severity. They must be in good health, with normal heart rate and blood pressure, and not undergoing other treatments that could interfere. Parents or guardians must consent to the study's duration.Check my eligibility

What is being tested?

The trial tests HLD200 methylphenidate hydrochloride capsules (20 mg & 40 mg) against placebo capsules to assess their effectiveness, safety, and how the body processes them in young children with ADHD when taken in the evening.See study design

What are the potential side effects?

Potential side effects of HLD200 may include sleep problems, decreased appetite, stomach pain, nausea, increased heart rate/blood pressure. These are common side effects of stimulant medications used for treating ADHD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My child is between 4 and 5 years old.

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I have been diagnosed with ADHD according to DSM-5 and confirmed by MINI KID.

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I have ADHD with symptoms that need treatment, confirmed by specific test scores.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (baseline), day 8, day 15, day 22

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (baseline), day 8, day 15, day 22

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline), day 8, day 15, day 22 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in ADHD Rating Scale-IV (ADHD RS IV) Preschool Version

Secondary study objectives

Change in Clinical Global Impression - Severity (CGI-S)

PK parameter: area under the plasma concentration-time curve (AUC) at steady-state (AUCss)

PK parameter: maximum plasma concentration (Cmax)

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: HLD200 40 mgExperimental Treatment1 Intervention

HLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for the first week (prescribed at Visit 2), with up-titration for the final 2 weeks to HLD200 20 mg active capsules (×2) (prescribed at Visits 3 and 4)

Group II: HLD200 20 mgExperimental Treatment1 Intervention

HLD200 20 mg placebo capsule (×1) and HLD200 20 mg active capsule (×1) for 3 weeks (prescribed at Visits 2, 3, and 4)

Group III: Placebo ComparatorPlacebo Group1 Intervention

Matching placebo to HLD200 20 mg capsule (×2) for 3 weeks (prescribed at Visits 2, 3, and 4)

0 / 3Eligibility criteria met