20
Participants
Start Date
January 31, 2012
Primary Completion Date
February 28, 2017
Study Completion Date
February 28, 2017
Drug-Carbamazepine (Tegretol XR)
To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated..
Carbamazepine (Tegretol XR) Placebo
Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine.
Children's Hospital of Pittsburgh, UPMC, Pittsburgh
University of Pittsburgh Medical Center, Presbyterian Hospital, Pittsburgh
Washington University in St. Louis School of Medicine, St Louis
Collaborators (1)
Novartis
INDUSTRY
National Institutes of Health (NIH)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Pittsburgh
OTHER
Washington University School of Medicine
OTHER