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

NCT06431256 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-11-06

No results posted yet for this 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.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

HLD200 methylphenidate hydrochloride capsules

Doses: 20mg capsules

DRUG

Placebo HLD200 capsules

Doses: 20mg capsules

Sponsors & Collaborators

  • Collegium Pharmaceutical, Inc.

    collaborator INDUSTRY

  • Ironshore Pharmaceuticals and Development, Inc

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-13
Primary Completion
2025-07-11
Completion
2025-07-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06431256 on ClinicalTrials.gov