Many children with epilepsy remain medically intractable inspire of the best available therapies. One of the most difficult seizure types to treat is infantile spasms. Many children will respond to treatment with ACTH but there are may serious side effects and many children relapse when the medication is reduced or discontinued. Thus, new therapies are critically needed for this group of patients. Early evidence from European trials indicated that vigabatrin (Sabril) was effective in this population. A randomized, single blind, high-dose vs low dose vigabatrin study was performed in a multicenter USA trial. Between January 1996 and May 1997, 89 patients from 7 pediatric epilepsy centers were started in the study. An interim evaluation was performed on September 14, 1997. Of the 89 patients, data was not yet available for 16 so 73 patients were evaluable for safety. Efficacy was evaluated in 63 of the patients. Two were eliminated because they had violated the entry criteria and 8 did not yet report the efficacy information and had to be excluded from the interim report.
Adrenocorticotropic Hormone ; Child* ; Epilepsy* ; Humans ; Infant ; Infant, Newborn ; Recurrence ; Seizures ; Spasms, Infantile ; Vigabatrin*