Corrigendum to “Updated clinical recommendations for the management of tuberous sclerosis complex associated epilepsy” [Eur. J. Paediatr. Neurol. 47 (2023) 25-34, (S1090379823001332), (10.1016/j.ejpn.2023.08.005)]

Abstract

The authors regret to inform you that the following updated should be considered in the text of the manuscript. Paragraph on Pre-symptomatic treatment. Very recently results from the PREVeNT study have been published: this was a phase IIb multicenter randomized double-blind placebo-controlled trial. Patients were randomized to vigabatrin or placebo at the onset of epileptiform discharges. At the onset of clinical seizures patient on placebo transitioned to open label vigabatrin treatment. Eighty-four infants were enrolled in the study: the results revealed that the incidence of epileptic spasms was lower and time to spasms after randomization was later in the vigabatrin group. No differences were found in incidence of cognitive outcome at 24 months and occurrence of drug resistant epilepsy. The significant difference in proportion of patient with TSC 2 mutation between groups (97 % in vigabatrin group and 67 % in placebo group) -known to be associated with a more severe phenotype- and because of differences in study design the PREVENT and EPISTOP trials cannot be directly compared. Reference: Bebin EM, Peters JM, Porter BE et al. Early Treatment with Vigabatrin Does Not Decrease Focal Seizures or Improve Cognition in Tuberous Sclerosis Complex: The PREVeNT Trial. Ann Neurol. August 2023. https://doi.org/10.1002/ana.26778. We modified Table 2 accordingly. Ongoing RCTs, with the aim to prevent epilepsy, are summarized in Table 2. [Table presented] In Table 4 we corrected the dosage of Cannabidiol, which is approved up to 25mg/kg/day. See below updated Table 4. [Table presented] The authors would like to apologise for any inconvenience caused.