Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome

PHASE3CompletedINTERVENTIONAL
Enrollment

172

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

June 30, 2013

Conditions
Fragile X Syndrome
Interventions
DRUG

arbaclofen

5 mg bid

DRUG

arbaclofen

10 mg bid

DRUG

arbaclofen

10 mg tid

DRUG

Placebo

tid

Trial Locations (28)

10029

Seaver Autism Center, Mount Sinai Medical Center, New York

10314

New York State Institute for Basic Research in Developmental Disabilities, Staten Island

19063

Suburban Research Associates/Elwyn Genetics, Media

21205

Kennedy Krieger Institute, Baltimore

27710

Duke Clinical Research Unit, Durham

29646

Greenwood Genetics Center, Greenwood

30033

Emory University School of Medicine, Decatur

32763

Lake Mary Pediatrics, Orange City

33136

University of Miami, Mailman Center for Child Development, Miami

37203

Vanderbilt Kennedy Center, Nashville

44308

Akron Children's Hospital, Akron

45229

Cincinnati Children's Hospital, Cincinnati

48201

Children's Hospital of Michigan, Detriot

60612

Rush University Medical Center, Chicago

65211

University of Missouri, Thompson Research Center for Autism & Neurodevelopmental Disorders, Columbia

66205

Kansas University Clinical Research Center, Fairway

73117

University of Oklahoma, Physician's Child Study Center, Oklahoma City

75235

Childrens Medical Center Dallas, Dallas

77030

Texas Children's Hospital, Houston

77090

Red Oaks Psychiatry Associates, P.A., Houston

78258

Road Runner Research, San Antonio

80045

University of Colorado Denver, Children's Hospital, Aurora

85006

Southwest Autism Research & Resource Center, Phoenix

90806

Miller Children's Hospital, Long Beach

92108

Psychiatric Centers at San Diego, San Diego

95817

University of California-Davis, M.I.N.D. Institute, Sacramento

98101

Seattle Children's Hospital, Seattle

01605

University of Massachusetts, Worcester

All Listed Sponsors
lead

Seaside Therapeutics, Inc.

INDUSTRY

NCT01325220 - Efficacy and Safety Study of STX209 (Arbaclofen) for the Treatment of Social Withdrawal in Children With Fragile X Syndrome | Biotech Hunter | Biotech Hunter