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A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting

NCT02493777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2021-07-23

Study results available
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Summary

This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting. This study has a 6-week open-label treatment optimization period followed by a one week randomized, double-blind, placebo-controlled test phase.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

HLD200 methylphenidate hydrochloride (MPH) Capsules

HLD200 doses: 20, 40, 60, 80 or 100 mg

DRUG

Placebo

Sponsors & Collaborators

  • Ironshore Pharmaceuticals and Development, Inc

    lead OTHER

Principal Investigators

  • Ann Childress, MD · Center for Psychiatry And Behavioral Medicine Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-02-29
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02493777 on ClinicalTrials.gov