Prevention of epilepsy in infants with Tuberous Sclerosis Complex in the EPISTOP trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F21%3A10417598" target="_blank" >RIV/00064203:_____/21:10417598 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11130/21:10417598

Result on the web

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=7pZMYhydEw" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=7pZMYhydEw</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/ana.25956" target="_blank" >10.1002/ana.25956</a>

Result language

angličtina

Original language name

Prevention of epilepsy in infants with Tuberous Sclerosis Complex in the EPISTOP trial

Original language description

OBJECTIVE: Epilepsy develops in 70-90% of children with Tuberous Sclerosis Complex (TSC) and is often resistant to medication. Recently, the concept of preventive antiepileptic treatment to modify the natural history of epilepsy has been proposed. EPISTOP was a clinical trial designed to compare preventive versus conventional antiepileptic treatment in TSC infants. METHODS: In this multi-center study, 94 infants with TSC without seizure history were followed with monthly video electroencephalography (EEG), and received vigabatrin either as conventional antiepileptic treatment, started after the first electrographic or clinical seizure, or preventively when epileptiform EEG activity before seizures was detected. At six sites, subjects were randomly allocated to treatment in a 1:1 ratio in a randomized controlled trial (RCT). At four sites, treatment allocation was fixed, denoted an open-label trial (OLT). Subjects were followed until 2 years of age. The primary endpoint was the time to first clinical seizure. RESULTS: In 54 subjects epileptiform EEG abnormalities were identified before seizures. Twenty-seven were included in the RCT and 27 in the OLT. The time to the first clinical seizure was significantly longer with preventive than conventional treatment (RCT: 364 95% CI: 223, 535) vs. 124 days (95% CI: 33, 149); OLT: 426 (95% CI: 258, 628) vs. 106 days (95% CI: 11, 149). At 24 months, our pooled analysis showed preventive treatment reduced the risk of clinical seizures (odds ratio [OR] = 0.21, p = 0.032), drug-resistant epilepsy (OR = 0.23, p = 0.022), and infantile spasms (OR = 0, p &lt; 0.001). No adverse events related to preventive treatment were noted. INTERPRETATION: Preventive treatment with vigabatrin was safe and modified the natural history of seizures in TSC, reducing the risk and severity of epilepsy. This article is protected by copyright. All rights reserved.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30103 - Neurosciences (including psychophysiology)

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2021

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Annals of Neurology

ISSN

0364-5134

e-ISSN

—

Volume of the periodical

89

Issue of the periodical within the volume

2

Country of publishing house

US - UNITED STATES

Number of pages

11

Pages from-to

304-314

UT code for WoS article

000592500500001

EID of the result in the Scopus database

2-s2.0-85096638206