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

NCT02884544 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-07-19

No results posted yet for this study

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.

Conditions

  • Attention-Deficit Hyperactivity Disorder (ADHD)

Interventions

DRUG

HLD100

Treatment

Sponsors & Collaborators

  • Ironshore Pharmaceuticals and Development, Inc

    lead OTHER

Principal Investigators

  • Ann Childress, MD · Center for Psychiatry & Behavoural Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2016-12-18
Completion
2016-12-27

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 NCT02884544 on ClinicalTrials.gov