Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

June 30, 2009

Study Completion Date

August 31, 2009

Conditions
Autistic Disorder
Interventions
DRUG

methylcobalamin

Methylcobalamin (25,000μg/ml), at a dosage of 64.5μg/kg, or saline placebo administered subcutaneously, once every three days for six weeks. At six weeks, subjects cross over to the other treatment given every three days for another six weeks. Post 12 weeks, treatment with open label methylcobalamin will continue once every three days, for six months.

OTHER

saline placebo

Methylcobalamin (25,000μg/ml), at a dosage of 64.5μg/kg, or saline placebo administered subcutaneously, once every three days for six weeks. At six weeks, subjects cross over to the other treatment given every three days for another six weeks. Post 12 weeks, treatment with open label methylcobalamin will continue once every three days, for six months.

Trial Locations (1)

95817

UC Davis MIND Institute, Sacramento

All Listed Sponsors
lead

University of California, San Francisco

OTHER

NCT00273650 - Efficacy Study of Subcutaneous Methyl-B12 in Children With Autism | Biotech Hunter | Biotech Hunter