Trial reportEpilepsia open2025
Efficacy of naloxone in reducing hypoxemia and duration of immobility following focal to bilateral tonic-clonic seizures.
Trial report in Epilepsia open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
3 citing papers in PubMed.
- Efficacy of naloxone in reducing hypoxemia and duration of immobility following focal to bilateral tonic-clonic seizures.Epilepsia open · 2025Trial
- SUDEP update 2026: recent advances in experimental and clinical research.Current opinion in neurology · 2026Review
- Current perspectives in sudden unexpected death in epilepsy (SUDEP): epidemiology, research approaches and pathways to prevention.Neurological research and practice · 2026Review
Corrections and comments
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Authors and funding
23 authors.
Funding
Abstract
objectiveEvaluating 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).
methodsENALEPSY 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 REPO
results33 patients contributed to the NLX group, 7 to the PCB group, and 43 to the HC group. The proportion of FBTCS type 1 or 3 was 84% in NLX, 100% in PCB, and 84% in HC. NLX did not improve the delay of recovery of SpO SIGNIFICANCE: NLX did not prevent post-ictal respiratory dysfunction but might reduce the duration of post-ictal immobility. Confirmation of this effect and its impact on SUDEP risk will require additional studies. PLAIN LANGUAGE SUMMARY: Release of endogenous opioids might participate in the severity of post-ictal hypoxemia and immobility after focal to bilateral tonic-clonic seizures (FBTCS). We conducted a multicenter double-blind randomized placebo-controlled trial evaluating the efficacy of an opioid antagonist, naloxone (NLX), administered within 2 min following the end of FBTCS. The efficacy of NLX was further explored with a comparison with historical control. NLX did not improve the delay of recovery or the severity of post-ictal hypoxemia. Post-ictal immobility was significantly shorter in the NLX group when compared to historical control. The impact of these results on SUDEP prevention will require additional studies.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.