A 6-week, Study of MG01CI Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Fragile X Syndrome
Interventions
DRUG

MG01CI extended-release tablet

Metadoxine, MG01CI extended-release tablet taken for 6 weeks treatment. Starting with a dose of 700 mg for 2 weeks followed by a 2 weeks of 1400 mg and then 2 weeks of 700 mg or 1400 mg.

Trial Locations (12)

19063

Suburban Research Associates, Media

21205

Kennedy Krieger Institute, Baltimore

27710

Duke University Medical Center, Durham

45229

Cincinnati Children's Hospital, Cincinnati

60612

RUSH University Medical Center, Chicago

77030

Baylor College of Medicine Research, Houston

80045

Children's Hospital Colorado, Aurora

85006

Southwest Autism Research & Resource Center, Phoenix

95817

University of California Davis Pediatrics, Sacramento

98121

Univ. of Washington/Seattle Children's Hospital, Seattle

02115

Boston Children's Hospital, Boston

Unknown

Sheba Academic Medical Center, Ramat Gan

All Listed Sponsors
lead

Alcobra Ltd.

INDUSTRY

NCT02126995 - A 6-week, Study of MG01CI Low Dose and High Dose Compared With Placebo in Adults and Adolescents With Fragile X Syndrome | Biotech Hunter | Biotech Hunter