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

Attention Deficit Hyperactivity Disorder Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Hyperkinesis
Clinical Trial Details
NCT number NCT02255513
Study type Interventional
Source Ironshore Pharmaceuticals and Development, Inc
Contact
Status Completed
Phase Phase 3
Start date May 2014
Completion date October 2014
View Details
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