Efficacy of naloxone in reducing hypoxemia and duration of immobility following focal to bilateral tonic–clonic seizures
Year: 2025
Type: article
Abstract: ABSTRACT Purpose 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). Patient with a FBTCS during LTM were randomized 1:1 to receive intravenous NLX or PCB within the 2 minutes 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 2 MSE study whose characteristics matched those of patients randomized in ENALEPSY. Efficacy of NLX was then assessed versus PCB and versus HC. The primary endpoint was the delay between the end of the seizure and recovery of SpO 2 ≥ 90%. Secondary efficacy outcomes included desaturation nadir and duration of the postictal immobility. Results 33 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 2 ≥ 90% or the desaturation nadir. In contrast, duration of the postictal immobility differed across groups. The time to mobility recovery within the first 5 minutes post-ictal was very similar in PCB (200.3±215.8 seconds) and HC (194.4±192.0 second) groups, and significantly shorter in the NLX group (128.9±151.1 seconds) when compared to HC (Hazard Ratio, 1.84; 95% CI, 1.11 to 3.05; p=0.021). Conclusion NLX did not prevent postictal respiratory dysfunction but might reduce the duration of postictal immobility. Confirmation of this effect and its impact on SUDEP risk will require additional studies KEY BULLET POINTS – ENALEPSY trial evaluated the efficacy of intravenous naloxone to reduce the severity of post-ictal complications after focal to bilateral tonic-clonic seizures. – Naloxone did not improve the delay of recovery of SpO 2 ≥ 90% or the desaturation nadir – The time to mobility recovery was significantly shorter in the NLX group when compared to historical control – Impact of these results on SUDEP prevention will require additional studies
Source: Epilepsia Open
DOI: 10.1002/epi4.70046
Authors: Sylvain Rheims, Fatima Chorfa, Véronique Michel, Edouard Hirsch, Louis Maillard, Luc Valton, Fabrice Bartolomei, Philippe Derambure, Vincent Navarro, Julien Biberon, Arielle Crespel, Anca Nica, Martine Lemesle Martin, Laure Mazzola, Jerome Petit, Vincent Rossero, Sébastien Boulogne, Mathilde Leclercq, Laurent Bezin, Catherine Mercier, Pascal Roy, Philippe Ryvlin, the ENALEPSY Study Group
Institutions: Lyon 1 Université, Centre National de la Recherche Scientifique, Inserm, Centre de Recherche en Neurosciences de Lyon, Hospices Civils de Lyon, Hôpital Pellegrin, Hôpitaux Universitaires de Strasbourg, Centre Hospitalier Régional et Universitaire de Nancy, Centre de recherche cerveau et cognition, Hôpital de la Timone, Université de Lille, Sorbonne Université, Pitié-Salpêtrière Hospital, Institut du Cerveau, Université de Tours, Centre Hospitalier Universitaire de Tours, Centre Hospitalier Universitaire de Rennes, CHU Dijon Bourgogne, Centre Hospitalier Universitaire de Saint-Étienne, Centre Médical de La Teppe, Centre Hospitalier Universitaire Vaudois
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,120
OpenAlex ID: W4409869302