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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 is a Phase 3 study that was terminated before completion, run by Ironshore Pharmaceuticals and Development. The registered enrollment target is 26 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06431256
The ClinicalTrials.gov registry entry for NCT06431256 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ironshore Pharmaceuticals and Development, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which HLD200 methylphenidate hydrochloride capsules is the first listed.
NCT06431256 reports 0 study locations.
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.
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