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Stimulant

HLD200 40 mg for Attention Deficit Hyperactivity Disorder (ADHD)

Phase 3
Waitlist Available
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights

Summary

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 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.
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.
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Efficacy Endpoint
Secondary study objectives
Secondary Efficacy Endpoint

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908
51%
Appetite Loss
40%
Insomnia
33%
Irritability
29%
Picking at skin, nailbiting
21%
Dull, tired, listless
21%
Worried/Anxious
19%
Tearful, depressed
18%
Stomachache
13%
Headache
13%
Motor Tics
12%
Buccal-lingual movements
10%
Social Withdrawal
1%
Hospitalized
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1-Medication First
Phase 1 - Placebo First
Phase 2 - 7-Day Dosing
Phase 2 - 5-Day Dosing

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)

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Who is running the clinical trial?

Ironshore Pharmaceuticals and Development, IncLead Sponsor
6 Previous Clinical Trials
404 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
404 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
~112 spots leftby Jul 2026
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