Efficacy of Naloxone in Reducing Postictal Central Respiratory Dysfunction in Patients With Epilepsy

PHASE3CompletedINTERVENTIONAL
Enrollment

485

Participants

Timeline

Start Date

June 26, 2015

Primary Completion Date

July 30, 2020

Study Completion Date

July 30, 2020

Conditions
Epilepsy
Interventions
DRUG

naloxone

"A single dose of 1 ml of naloxone (i.e 0.4 mg) or placebo will be administered by the supervising nurse or physician, using direct intravenous injection with a 5 ml syringe through peripheral venous catheter of which all patients will be equipped throughout the video-EEG.~The evolution from a partial seizure to a GTCS being gradual, and the total duration of the seizure ranging from 2 to 3 minutes, the injection will be prepared during the course of the seizure. Given the assumptions about the role of endogenous opioids release in the spontaneous termination of seizures, naloxone will be administrated immediately after the end of the GTCS and not before. Specifically, treatment administration will be performed within the 2 minutes following the end of the GTCS."

DRUG

Placebo

"Placebo will be isotonic sodium chloride which preparation in 1 ml vials will be centralized by the pharmaceutical department of Edouard Herriot Hospital to ensure its indistinguishability from naloxone A single dose of 1 ml of naloxone (i.e 0.4 mg) or placebo will be administered by the supervising nurse or physician, using direct intravenous injection with a 5 ml syringe through peripheral venous catheter of which all patients will be equipped throughout the video-EEG.~The evolution from a partial seizure to a GTCS being gradual, and the total duration of the seizure ranging from 2 to 3 minutes, the injection will be prepared during the course of the seizure. Given the assumptions about the role of endogenous opioids release in the spontaneous termination of seizures, naloxone will be administrated immediately after the end of the GTCS and not before. Specifically, treatment administration will be performed within the 2 minutes following the end of the GTCS."

Trial Locations (1)

Unknown

Service de Neurologie Fonctionnelle et d'Epileptologie et Institut des Epilepsies Hôpital Neurologique, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT02332447 - Efficacy of Naloxone in Reducing Postictal Central Respiratory Dysfunction in Patients With Epilepsy | Biotech Hunter | Biotech Hunter