Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

PHASE3CompletedINTERVENTIONAL
Enrollment

199

Participants

Timeline

Start Date

September 6, 2017

Primary Completion Date

October 23, 2018

Study Completion Date

October 23, 2018

Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Interventions
DRUG

Placebo

Placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.

DRUG

SPD489 (Lisdexamfetamine dimesylate)

SPD489 capsule in a 5:5:5:5:6 ratio to 5, 10, 20, 30 mg orally once daily for 6 weeks.

DRUG

SPD489

SPD489

Trial Locations (48)

10036

Manhattan Behavioral Medicine, New York

14642

University of Rochester, Rochester

21205

Kennedy Krieger Institute, Baltimore

23805

Clinical Research Partners, LLC, Petersburg

29407

Carolina Clinical Trials, Inc., Charleston

29464

Coastal Carolina Research, Mt. Pleasant

29812

Rainbow Research Inc, Barnwell

30030

iResearch Atlanta LLC, Decatur

32256

Clinical Neuroscience Solutions, Inc., Jacksonville

32607

Sarkis Clinical Trials, Gainesville

32720

Avail Clinical Research, LLC, DeLand

32763

Medical Research Group of Central Florida, Orange City

32801

Clinical Neuroscience Solutions, Orlando

32803

APG Research, LLC, Orlando

33613

University of South Florida Department Of Psychiatry, Tampa

33701

University of South Florida, St. Petersburg

36303

Harmonex, Inc, Dothan

38119

Clinical Neuroscience Solutions, Inc, Memphis

44106

University Hospitals Case Medical Center, Cleveland

45014

Pediatric Associates of Fairfield, Inc, Fairfield

48306

Rochester Center for Behavioral Medicine, Rochester Hills

48314

Clinical Neurophysiology Services, Sterling Heights

63110

Washington University, St Louis

68526

Premier Psychiatric Reseach Institute, LLC, Lincoln

70629

Lake Charles Clinical Trials, Lake Charles

72211

Preferred Research Partners, Inc, Little Rock

73103

IPS Research Company, Oklahoma City

73112

Oklahoma Clinical Research Center, Oklahoma City

73118

Paradigm Research Professionals, Oklahoma City

73120

Cutting Edge Research Group, Oklahoma City

77007

Bayou City Research Limited, Houston

77084

BI Research Center, Houston

77090

Red Oak Psychiatry Associates, Houston

77381

Family Psychiatry of the Woodlands, The Woodlands

78249

Road Runner Research, San Antonio

78759

BioBehavioral Research of Austin, Austin

84015

Ericksen Research and Development, Clinton

90807

Alliance for Wellness d/b/a Alliance for Research, Long Beach

91402

Asclepes Research, Panorama City

92108

Psychiatric Centers at San Diego, San Diego

92251

Sun Valley Research Center, Imperial

92324

CMB Clinical Trials, Colton

92595

Elite Clinical Trials, Inc, Wildomar

94143

UCSF Dept of Psychiatry, San Francisco

97030

Cyn3rgy Research Center, Gresham

98007

Northwest Clinical Research Center, Bellevue

98105

Seattle Childrens Hospital, Pearl Clinic, Seattle

07753

Jersey Shore University Medical Center (JSUMC), Neptune City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY

NCT03260205 - Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD) | Biotech Hunter | Biotech Hunter