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

PHASE3CompletedINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

February 29, 2016

Study Completion Date

March 31, 2016

Conditions
Attention Deficit Hyperactivity Disorder
Interventions
DRUG

HLD200 methylphenidate hydrochloride (MPH) Capsules

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

DRUG

Placebo

Trial Locations (7)

32751

Florida Clinical Research Center, LLC, Maitland

34201

Florida Clinical Research Center, LLC, Bradenton

77007

Bayou City Research, Ltd, Houston

79423

Westex Clinical Investigations, Lubbock

89128

Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas

92660

AVIDA Inc., Newport Beach

02050

South Shore Psychiatric Services, PC, Marshfield

All Listed Sponsors
lead

Ironshore Pharmaceuticals and Development, Inc

OTHER