Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD
Public ClinicalTrials.gov record NCT06431256. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 3, Multicenter, 3-Week Fixed-dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy, Safety and PK Study of Evening Dosed Methylphenidate Hydrochloride ER Capsules (HLD200) in Children Aged 4-5 Years With ADHD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06431256
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 26 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 4 Years to 5 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 13, 2024 (Actual)
- Primary completion
- Jul 11, 2025 (Actual)
- Completion
- Jul 11, 2025 (Actual)
- Last update posted
- Nov 6, 2025
2024 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Harmonex, Inc. | Dothan | Alabama | 36303 | — |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | — |
| South Florida Research | Miami Springs | Florida | 33166 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | — |
| CenExel iResearch, LLC | Decatur | Georgia | 30030 | — |
| DelRicht Research | New Orleans | Louisiana | 70115 | — |
| Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Alivation Research, LLC | Lincoln | Nebraska | 68526 | — |
| Vector Clinical Trials | Las Vegas | Nevada | 89128 | — |
| University of Cincinnati Health | Cincinnati | Ohio | 45219 | — |
| Coastal Pediatric Research | Summerville | South Carolina | 29486 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06431256, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 6, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06431256 live on ClinicalTrials.gov.