F. Randy Sallee, MD, PhD

Efficacy and Safety of a Delayed-Release and Extended-Release Methylphenidate Formulation in Children With ADHD: Results From a Pivotal Phase 3 Trial in a Naturalistic Setting

Purpose: Evening-dosed HLD200 is a delayed-release and extended-release methylphenidate (DR/ER-MPH) designed to provide treatment effect in the early morning, throughout the day, and into...

Steven Pliszka , MD;

Jeffrey Newcorn , MD;

Samantha Bostrom , MD;

Frank López , MD;

Andrea Marraffino , PhD;

Norberto DeSousa , MA;

Bev Incledon , PhD;

F. Randy Sallee , MD, PhD;

Andrew J. Cutler , MD;

Valerie Arnold , MD;

Timothy Wilens , MD;

11/22/2019

Improvements in At-Home Functional Impairment With DR/ER-MPH in Children With Attention-Deficit/Hyperactivity Disorder (ADHD): Post Hoc Analysis of BSFQ and PREMB-R by Norm-Referenced Cut-Offs

Background: Age-adjusted cut-offs for two scales of ADHD-related at-home functional impairment, the Before School Functioning Questionnaire (BSFQ) and the Parent Rating of Evening and Mor...

Steven Pliszka , MD;

F. Randy Sallee , MD, PhD;

Jeffrey Newcorn , MD;

Stephen V. Faraone , PhD;

Norberto DeSousa , MA;

Timothy Wilens , MD;

Bev Incledon , PhD;

03/01/2019

Clinically Meaningful Improvements With DR/ER-MPH in At-Home Functional Impairment During the Early Morning and Late Afternoon/Evening in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)

Background: In a pivotal, randomized, double-blind, placebo-controlled, phase 3 trial of children (6–12y) with ADHD (NCT02520388), treatment with HLD200, an evening-dosed, delayed-release...

Norberto DeSousa , MA;

Bev Incledon , PhD;

F. Randy Sallee , MD, PhD;

Stephen V. Faraone , PhD;

Timothy Wilens , MD;

Paul Hammerness , MD;

Steven Pliszka , MD;

Jeffrey Newcorn , MD;

03/01/2019

A Randomized, Double-Blind, Placebo-Controlled Study of Delayed-Release and Extended-Release Methylphenidate in Children With ADHD: An Evaluation of Safety and Efficacy Throughout the Day and Across Settings

Purpose: Evening-dosed HLD200 is a delayed-release and extended-release methylphenidate (DR/ER-MPH) designed to provide treatment effect in the early morning, throughout the day, and into...

Andrew J. Cutler , MD;

Ann Childress , MD;

Andrea Marraffino , PhD;

Norberto DeSousa , MA;

Bev Incledon , PhD;

F. Randy Sallee , MD, PhD;

Sharon Wigal , PhD;

11/22/2019