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ABSTRACT: Objective
Evaluating the efficacy of an opioid antagonist, naloxone (NLX), to reduce the severity of post-ictal hypoxemia and immobility after focal to bilateral tonic-clonic seizures (FBTCS).Methods
ENALEPSY is a double-blind placebo (PCB)-controlled trial conducted in patients with focal epilepsy undergoing long-term video-EEG monitoring (LTM). Patients with a FBTCS during LTM were randomized 1:1 to receive intravenous NLX or PCB within the 2 min following the end of FBTCS. After database lock, a discrepancy between the allocated arm and the received treatment was detected, resulting in a 4:1 NLX:PCB ratio. To further explore the efficacy of NLX, we used historical control (HC) data collected in patients included in the REPO2MSE study whose characteristics matc
SUBMITTER: Rheims S
PROVIDER: S-EPMC12163546 | biostudies-literature | 2025 Jun
REPOSITORIES: biostudies-literature