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- Title
Vigabatrin for the Treatment of Infantile Spasms: Final Report of a Randomized Trial.
- Authors
Elterman, Roy D.; Shields, W. Donald; Bittman, Richard M.; Torri, Sarah A.; Sagar, Stephen M.; Collins, Stephen D.
- Abstract
A large randomized study was conducted in patients with newly diagnosed infantile spasms to compare 2 doses of vigabatrin in achieving spasm cessation. High (100-148 mg/kg/d) and low (18-36 mg/kg/d) oral doses of vigabatrin were evaluated in a randomized, single-blind study of 14 to 21 days with subsequent open-label treatment up to 3 years. Spasm cessation was defined as 7 consecutive days of spasm freedom beginning within the first 14 days, confirmed by video-electroencephalogram. A total of 221 subjects comprised the modified intent-to-treat cohort. More subjects in the high-dose group achieved spasm cessation compared with the low-dose vigabatrin group (15.9% [17/107] vs 7.0% [8/114]; P = .0375). During follow-up, 39 of 171 (23%) subjects relapsed; 28 of 39 (72%) regained spasm freedom. Adverse events were primarily mild to moderate in severity. Vigabatrin had a dose-dependent effect in spasm reduction. Spasm cessation occurred rapidly and was maintained in the majority of infants.
- Subjects
INFANTILE spasms; VIGABATRIN; INFANT diseases; INTELLECTUAL disabilities; CHILDHOOD epilepsy; THERAPEUTICS
- Publication
Journal of Child Neurology, 2010, Vol 25, Issue 11, p1340
- ISSN
0883-0738
- Publication type
Article
- DOI
10.1177/0883073810365103