84
Participants
Start Date
December 31, 2016
Primary Completion Date
April 26, 2023
Study Completion Date
May 5, 2023
Early Vigabatrin
Subjects randomized to vigabatrin will be treated with vigabatrin 100mg/kg/day until 24 months of age or until they show evidence of clinical seizures or electrographic seizures on video EEG. If electrographic or clinical seizures occur while on study drug, they will transition into the Open label phase of the study and continue to be followed until 36 months of age.
Delayed Vigabatrin (Placebo)
Subjects randomized to placebo will be treated with matching placebo at 100mg/kg/day until 24 months of age or until they show evidence of clinical seizures or electrographic seizures on video EEG. If electrographic or clinical seizures occur while on study drug, they will transition into the Open label phase of the study and continue to be followed until 36 months of age.
The Children's Hospital of Philadelphia, Philadelphia
Children's National Medical Center, Washington D.C.
University of Alabama at Birmingham, Birmingham
Duke University, Durham
Cincinnati's Children Hospital Medical Center, Cincinnati
Beaumont Children's Hospital, Royal Oak
Minnesota Epilepsy Group, PA, Saint Paul
Washington University in St. Louis, St Louis
University of Texas Health Science Center at Houston, Houston
University of California, Los Angeles, Los Angeles
Stanford University, Palo Alto
Seattle Children's Hospital, Seattle
Boston Children's Hospital, Boston
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Martina Bebin
OTHER