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

PHASE3CompletedINTERVENTIONAL
Enrollment

163

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

April 30, 2016

Study Completion Date

May 31, 2016

Conditions
Attention Deficit Hyperactivity Disorder
Interventions
DRUG

HLD200 methylphenidate hydrochloride (MPH) Capsules

HLD200 Doses: 40, 60 or 80 mg

DRUG

Placebo

Trial Locations (21)

27705

Duke University Medical Center, Duke Child and Family Study Center, Durham

32256

Clinical Neuroscience Solutions, Inc, Jacksonville

32607

Sarkis Clinical Trials, Gainesville

32751

Florida Clinical Research Center, LLC, Maitland

32763

Medical Research Group of Central Florida, Orange City

32792

Children's Developmental Center, P.A., Winter Park

32801

Clinical Neuroscience Solutions, Inc., Orlando

33143

QPS MRA, dba Miami Research Associates, LLC, South Miami

33161

Scientific Clinical Research, Inc., North Miami

34201

Florida Clinical Research Center, LLC, Bradenton

38119

Clinical Neuroscience Solutions, Inc., Memphis

42301

Pedia Research, LLC, Owensboro

73103

IPS Research Company, Oklahoma City

73116

Cutting Edge Research Group, Oklahoma City

77007

Bayou City Research, Ltd, Houston

77090

Red Oak Psychiatry Associates, PA, Houston

78229

University of Texas Health Science Center at San Antonio, San Antonio

79423

Westex Clinical Investigations, Lubbock

84015

Ericksen Research and Development, Clinton

92660

AVIDA, Newport Beach

98105

Seattle Children's Hospital, Seattle

All Listed Sponsors
lead

Ironshore Pharmaceuticals and Development, Inc

OTHER

NCT02520388 - A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Naturalistic Setting | Biotech Hunter | Biotech Hunter