NCT02255513

A Trial Evaluating the Efficacy and Safety of HLD200 in Children With ADHD

A Phase III Clinical Endpoint Evaluation Study Examining the Safety and Efficacy of HLD200 in Pediatric Subjects With Attention-Deficit Hyperactivity Disorder.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Ironshore Pharmaceuticals and Development, Inc · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the efficacy and safety of HLD200 in patients age 6-12 years with ADHD using a classroom study design.

Detailed description

The study consists of two distinct treatment phases. The first is the 6-week open-label, treatment optimization phase during which subjects are titrated to an optimal daily dose of HLD200. Subjects are then randomized to receive either optimal HLD200 or matched placebo treatment for an additional week prior to final testing during a laboratory school day.

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	HLD200
DRUG	Placebo

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-10-02
• Last updated: 2021-06-30
• Results posted: 2021-02-10

Locations

4 sites across 1 country: United States