Trial · NCT06431256
Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD
NCT06431256, Phase 3, Terminated, Ironshore Pharmaceuticals and Development, Inc
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD. Trials, record NCT06431256. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06431256
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety & Pharmacokinetic (PK) Study of HLD200 in Children Aged 4-5 Years With ADHD
- NCT number
- NCT06431256
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 26 participants, actual
- Lead sponsor
- Ironshore Pharmaceuticals and Development, Inc
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- HLD200 methylphenidate hydrochloride capsules, Placebo HLD200 capsules
- First posted
- 2024-05-28
- Last updated
- 2025-11-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in ADHD Rating Scale-IV (ADHD RS IV) Preschool Version | Day 1 (Baseline), Day 8, Day 15, Day 22 | 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. |
| Secondary | Change in Clinical Global Impression - Severity (CGI-S) | Day 1 (Baseline), Day 8, Day 15, Day 22 | The investigator, or qualified designee, will rate the severity of a subject's condition on a 7-point scale ranging from 1 (normal) to 7 (among the most extremely ill subjects). |
| Secondary | PK parameter: area under the plasma concentration-time curve (AUC) at steady-state (AUCss) | Day 22 | The PK of MPH will be determined using a single plasma sample collected at the end of treatment (Visit 5). Subjects will be randomly assigned to 1 of 4 PK sampling time points (11 hours, 14 hours, 18 hours, or 24 hours post-dose) for this single sample collection at Visit 5. The AUCss will be calculated based on the population PK model's individual predicted concentrations. |
| Secondary | PK parameter: maximum plasma concentration (Cmax) | Day 22 | The PK of MPH will be determined using a single plasma sample collected at the end of treatment (Visit 5). Subjects will be randomly assigned to 1 of 4 PK sampling time points (11 hours, 14 hours, 18 hours, or 24 hours post-dose) for this single sample collection at Visit 5. The Cmax will be calculated based on the population PK model's individual predicted concentrations. |
| Secondary | PK parameter: time to maximum plasma concentration (Tmax) | Day 22 | The PK of MPH will be determined using a single plasma sample collected at the end of treatment (Visit 5). Subjects will be randomly assigned to 1 of 4 PK sampling time points (11 hours, 14 hours, 18 hours, or 24 hours post-dose) for this single sample collection at Visit 5. The Tmax will be calculated based on the population PK model's individual predicted concentrations. |
| Secondary | PK parameter: terminal elimination rate constant (λz) | Day 22 | The PK of MPH will be determined using a single plasma sample collected at the end of treatment (Visit 5). Subjects will be randomly assigned to 1 of 4 PK sampling time points (11 hours, 14 hours, 18 hours, or 24 hours post-dose) for this single sample collection at Visit 5. The λz will be calculated based on the population PK model's individual predicted concentrations. |
| Secondary | PK terminal elimination half-life (t1/2) | Day 22 | The PK of MPH will be determined using a single plasma sample collected at the end of treatment (Visit 5). Subjects will be randomly assigned to 1 of 4 PK sampling time points (11 hours, 14 hours, 18 hours, or 24 hours post-dose) for this single sample collection at Visit 5. The t1/2 will be calculated based on the population PK model's individual predicted concentrations. |
| Secondary | treatment-emergent adverse events (TEAEs) | Up to 5 weeks | A TEAE is any newly occurring adverse event since the initiation of study drug treatment or any adverse event already present at the initiation of study drug treatment that worsens in either intensity or frequency during or after exposure to study drug treatment. Any clinically significant abnormal changes to ECG assessments, vital signs, clinical lab results, physical examinations, or sleep disturbance, or any suicidality during the trial, will be recorded as adverse events (unless they are signs/symptoms of a diagnosis already recorded as an AE). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06431256
GET https://conductscience.org/api/trials/v1/NCT06431256/registered