NCT01793441 - A Study of RG7314 to Investigate Efficacy and Safety in Individuals With Autism Spectrum Disorders (ASD) | Biotech Hunter

Enrollment

223

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions

Autism Spectrum Disorder

Interventions

DRUG

Placebo

Placebo will be administered in different stages of the study for 12 weeks.

DRUG

RG7314

RG7314 will be administered orally at a dose of 1.5 mg/day in Stage I, 4 mg/day in Stage II, 10 mg/day in Stage III and 1.5 mg/day or 10 mg/day in Stage IV for 12 weeks.

Trial Locations (56)

10029

Mount Sinai School of Medicine; Seaver Autism Center, New York

New York

10467

Montefiore Medical Center; Departments of Psychiatry & Biobehavioral Science, The Bronx

The Bronx

10962

Nathan S. Kline Institute for Psychiatric Research, Orangeburg

Orangeburg

20852

Neuroscientific Insights, Rockville

Rockville

21205

The Kennedy Krieger Institute, Baltimore

Baltimore

27705

DUKE SCHOOL OF MEDICINE;Duke Center for Autism and Brain Development, Durham

Durham

30033

Emory University School of Medicine; Department of Human Genetics & Pediatrics, Decatur

Decatur

32806

Compass Research, Orlando

Orlando

33334

Research Centers of America, LLC, Oakland Park

Oakland Park

33445

Neurology offices of south florida, Delray Beach

Delray Beach

37232

Vanderbilt Medical Center, Nashville

Nashville

44106

University Hospitals, Cleveland

Cleveland

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

Cincinnati

55414

University of Minnesota; Clin. Neuro Research Unit, Minneapolis

Minneapolis

60612

Rush University Medical Center, Chicago

Chicago

78258

Road Runner Research, San Antonio

San Antonio

80112

DBA IMMUNOe Int'l Res Center, Centennial

Centennial

85006

Southwest Autism Research & Resource Center, Phoenix

Phoenix

92108

PCSD Feighner Research, San Diego

San Diego

92705

Santa Ana

94115

University of California at San Francisco, San Francisco

San Francisco

94305

Stanford

95817

University of California Davis, Sacramento

Sacramento

98007

Northwest Clinical Research Center, Bellevue

Bellevue

98011

Pacific Institute of Medical Sciences, Bothell

Bothell

98145

Seattle Children's Research Institute, Seattle

Seattle

06510

Yale University; Yale Child Study Center, New Haven

New Haven

02421

Massachusetts General Hospital, Lexington

Lexington

15203 1101

UPMC Western Psychiatric Institute and Clinic, Pittsburgh

Pittsburgh

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY