Could a single shot of naloxone after a seizure save lives?
NCT ID NCT02332447
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a single dose of naloxone, given right after a generalized tonic-clonic seizure, can help people with epilepsy breathe better and avoid sudden death. Researchers enrolled 485 adults with drug-resistant epilepsy who were already in the hospital for monitoring. The goal was to see if naloxone could speed up recovery of oxygen levels after a seizure, compared to a placebo.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- naloxone
- What this could lead to
- If it works, this could point toward a way to prevent sudden death in epilepsy by using a drug that blocks opioids to restore normal breathing after a seizure.
- What could go wrong
- This is a proof-of-concept study testing a single dose right after a seizure, not a long-term solution. It may not work in real-world settings, and blocking opioids could theoretically worsen seizures.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
485 people
The number who actually took part.
- Started
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Jun 2015
- Finished
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Jul 2020
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * For inclusion * Adult patient (≥ 18 years) suffering from drug-resistant partial epilepsy * Patient undergoing long-term video-EEG monitoring in one of the participating centre to record and characterize its seizure * Patient who gave its written informed consent to participate to the study For randomization * Patient who suffers a secondary generalized tonic-clonic seizure during the long-term video-EEG monitoring while being supervised by a nurse or a physician Exclusion Criteria: * Age \< 18 years * Patient that has already been randomized in this study * Pregnant or breastfeeding women * Hypersensitivity to naloxone * History of severe heart disease (myocardial infarction, heart failure disorder, arrhythmia severe hypertension) * Ongoing opioïd treatment, including both pure agonists and partial agonists * Addiction to opioïds, heroin, or any similar substance * Patient participating in another drug trial for less than 2 months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies Hôpital Neurologique
Lyon, France
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Other studies related to the condition(s) this trial covers.
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