Vigabatrin Treatment Prior to Seizures Decreased the Proportion of EEGs With Epileptiform Activity in Infants With Tuberous Sclerosis Complex During the PREVeNT Trial
Document Type
Conference Proceeding
Publication Date
12-6-2025
Abstract
Rationale: The PREVeNT trial enrolled 84 infants with tuberous sclerosis complex (TSC), using the presence of epileptiform activity on a one-hour EEG over the course of the first 24 months to randomize into a blinded arm of the trial comparing placebo to early vigabatrin at 100 milligrams/kilogram per day. Once patients developed clinical or electrographic seizures, they were treated with vigabatrin as standard of care. Of interest was whether early administration of vigabatrin would delay the onset of seizures or mitigate neurocognitive delay. Initial study results have been published: the early vigabatrin group had an overall lower incidence and later onset of infantile spasms; however, no differences were found in neurodevelopmental outcomes or the incidence of focal seizures at 24 months. Here we evaluate the effect of early vigabatrin on EEG epileptiform activity. Methods: A total of 793 EEGs were collected over the course of the study: subjects underwent an EEG every 6 weeks/1st year of life, every 3 months/ 2nd year of life and a single EEG at 36 months of age. All EEGs were reviewed by at least two electrophysiologists blinded to treatment group for the presence or absence of epileptiform activity; if they disagreed then a third reviewer adjudicated. Results: Of the 793 EEGs, 33.5% had epileptiform activity. 12 patients had 115 consistently normal EEGs throughout the study; they were not randomized and never developed seizures. There was a higher percentage of EEGs with epileptiform activity in the placebo arm of the study (n=27, 45.9 % of 296 EEGs) compared to those in the early vigabatrin group (n=29, 34.3% of 332 EEGs) Wilcoxon Rank-sum p=0.0290 . The difference in epileptiform activity by treatment group was stable over the study duration. The early vigabatrin group that never developed infantile spasms were the driver of the reduced number of EEGs with epileptiform activity. Placebo n=15/27 without spasms, 41.3% of EEGs had epileptiform activity; versus early vigabatrin n= 23/29 without spasms, 27.7% of the EEGSs had epileptiform activity, Wilcoxon Rank-sum p=0.0383. In contrast the placebo group with spasms n= 12/27 had 51.9% of their EEGs with epileptiform activity versus early vigabatrin n=6/29 with spasms had 60.3% of their EEGs with epileptiform activity, Wilcoxon Rank-sum p=0.4817. Regardless of treatment assignment, patients with epileptic spasms n=18, 54.8% of their EEGs had epileptic activity versus patients without spasms n=38, 32.9% of their EEGs had epileptic activity, Wilcoxon Rank-sum p=0.0009. Conclusions: Treatment with vigabatrin at first detection of epileptiform activity on an EEG decreased by ~10% the overall proportion of EEGs with epileptiform activity up to 3 years of age. Patients in the early vigabatrin treatment group without epileptic spasm drove the reduction in the frequency of epileptiform EEGs . Early vigabatrin did not impact the number of epileptiform EEGs in subjects eventually developing epileptic spasms. History of epileptic spasms in either treatment group was associated with the highest percentage of epileptiform EEGs across the duration of the study.
Recommended Citation
McPherson T, Bebin M, O'Kelley S, Sahin M, Taub K, Rajaraman R, et al. [Nolan D]. Vigabatrin treatment prior to seizures decreased the proportion of EEGs with epileptiform activity in infants with tuberous sclerosis complex during the PREVeNT trial. Presented at: American Epilepsy Society Annual Meeting; 2025 Dec 6; Atlanta, GA. Available from:https://aesnet.org/abstractslisting/vigabatrin-treatment-prior-to-seizures-decreased-the-proportion-of-eegs-with-epileptiform-activity-in-infants-with-tuberous-sclerosis-complex-during-the-prevent-trial
Comments
American Epilepsy Society Annual Meeting, December 5-9, 2025, Atlanta, GA