NCT06431256

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Ironshore Pharmaceuticals and Development, Inc · Academic / Other
• Sex: All
• Age: 4 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, 3 week fixed dose, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and pharmacokinetics of HLD200 (20 mg and 40 mg) in children aged 4 to 5 years with ADHD. Participants will be screened for eligibility for up to 4 weeks. Eligible participants will be treated with study medication for 3 weeks followed by a 2 week safety follow-up following the end of study treatment. The total duration of the study is up to 9 weeks. A single pharmacokinetic (PK) sample will be taken from each participant, in a prespecified PK sampling window at visit 5, for population PK analysis. A total of 168 participants (56 per treatment arm) will be randomized at Visit 2.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	HLD200 methylphenidate hydrochloride capsules	Doses: 20mg capsules
DRUG	Placebo HLD200 capsules	Doses: 20mg capsules

Timeline

• Start date: 2024-09-13
• Primary completion: 2025-07-11
• Completion: 2025-07-11
• First posted: 2024-05-28
• Last updated: 2025-11-06

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study