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

> **NCT06431256** · PHASE3 · TERMINATED · sponsor: **Ironshore Pharmaceuticals and Development, Inc** · enrollment: 26 (actual)

## Conditions studied

- Attention Deficit Hyperactivity Disorder

## Interventions

- **DRUG:** HLD200 methylphenidate hydrochloride capsules
- **DRUG:** Placebo HLD200 capsules

## Key facts

- **NCT ID:** NCT06431256
- **Lead sponsor:** Ironshore Pharmaceuticals and Development, Inc
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2024-09-13
- **Primary completion:** 2025-07-11
- **Final completion:** 2025-07-11
- **Target enrollment:** 26 (ACTUAL)
- **Why stopped:** FDA release from this PMR study due to their required class-labeling, with a limitation of use for all ER stimulants in pediatric patients under 6 years of age, based on results from studies with other ER stimulants in this age group.
- **Last updated:** 2025-11-06

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06431256

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06431256, "Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD". Retrieved via AI Analytics 2026-07-19 from https://api.ai-analytics.org/clinical/NCT06431256. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*