NCT02884544

A Study of Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) in Children With ADHD

Phase II, Open-label, Dose-titration, Safety Study Designed to Determine the Evening Dose of a Novel Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) to Produce Optimal Clinical Effects in Children With ADHD

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Ironshore Pharmaceuticals and Development, Inc · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.

Detailed description

This dose-escalation study will examine HLD100 in 24 subjects. The subjects (n=24) will be tested with HLD100 in ascending doses from 10mg up to 40mg. This study will be divided into several phases: Screening, Active Treatment and Follow-Up. All visits have a 2 day window to allow for scheduling.

Conditions

• Attention-Deficit Hyperactivity Disorder (ADHD)

Interventions

Type	Name	Description
DRUG	HLD100	Treatment

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-12-18
• Completion: 2016-12-27
• First posted: 2016-08-31
• Last updated: 2021-07-19

Locations

1 site across 1 country: United States