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NCT06431256 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD
A Phase 3 study, sponsored by Ironshore Pharmaceuticals and Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 26
- Enrollment target
NCT06431256: Clinical Trial Phase 3 study, sponsored by Ironshore Pharmaceuticals and Development.
NCT06431256 is a Phase 3 study that was terminated before completion, run by Ironshore Pharmaceuticals and Development. The registered enrollment target is 26 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06431256, a Phase 3 study, was terminated before completion, sponsored by Ironshore Pharmaceuticals and Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 26 participants
- Enrollment target
Study 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.
Primary Outcome
The ADHD RS-IV Preschool Version measures the behaviors of children with ADHD and provides examples appropriate for the developmental level of preschool children. It is an 18-item questionnaire that requires the respondent to rate the frequency of occurrence of ADHD symptoms (as defined by DSM-IV-TR criteria) using a 4-point scale from 0 (rarely or never) to 3 (very often), with the total score ranging from 0 to 54; a decrease in score indicates an improvement in ADHD symptomology.
Interventions
- DRUG HLD200 methylphenidate hydrochloride capsules
- DRUG Placebo HLD200 capsules
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2024-09-13 |
| Est. Completion | 2025-07-11 |
| Phase | Phase 3 |
Why NCT06431256 stopped before completion
NCT06431256 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which HLD200 methylphenidate hydrochloride capsules is the first listed.
NCT06431256 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06431256 about?
NCT06431256 is a clinical study titled "Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD". 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.
What is the current status of trial NCT06431256?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 26 participants. The study started on 2024-09-13. Estimated completion is 2025-07-11.
What interventions are being tested in trial NCT06431256?
The interventions under investigation include: HLD200 methylphenidate hydrochloride capsules (DRUG), Placebo HLD200 capsules (DRUG).
Who is sponsoring clinical trial NCT06431256?
This trial is sponsored by Ironshore Pharmaceuticals and Development, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06431256's enrollment target sits among peer trials
26 1937th of 2000 higher than 60 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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