ENALEPSIE EFFICACY OF NALOXONE IN REDUCING POSTICTAL CENTRAL RESPIRATORY DYSFUNCTION IN PATIENTS WITH EPILEPSY.

ENALEPSIE EFFICACY OF NALOXONE IN REDUCING POSTICTAL CENTRAL RESPIRATORY DYSFUNCTION IN PATIENTS WITH EPILEPSY. - ENALEPSIE

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003003-30-FR

Enrollment

Unknown

Registered

2015-06-18

Start date

2014-10-31

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden unexpected death in epilepsy (SUDEP) primarily affects young adults with drug-resistant epilepsy MedDRA version: 18.0 Level: LLT Classification code 10065336 Term: Partial epilepsy System Organ Class: 100000004852

Interventions

Trade Name: NALOXONE AGUETTANT 0,4 mg/ml, solution injectable Pharmaceutical Form: Solution for injection INN or Proposed INN: NALOXONE CAS Number: 465-65-6 Other descriptive name: NALOXONE Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age < 18 years 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of the study is to evaluate the efficacy of 0.4 mg intravenous naloxone, versus placebo, administered in the immediate aftermath of a GTCS, in reducing the severity of the postictal central respiratory dysfunction occurring after the end of the seizure, as measured by pulse oximetry.;Secondary Objective: Assess the impact of naloxone on respiratory parameters such as the frequency of apneas (> 10 seconds) occurring after the end of the seizure. Assess the impact of naloxone on 02 administration requirement and on cardiorespiratory rescue procedure requirement after the end of the seizure. Assess the impact of naloxone on the postictal generalized EEG suppression, the duration of which is correlated with the risk of SUDEP, and the severity of which could also result from a seizure-related release of endogenous opioids. Assess the impact of naloxone on the duration of the postictal coma following a GTCS, and the time required by the patient to recover preictal clinical condition. In the future, this clinical benefit might be enough significant to justify the systematic use of naloxone after GTCS in inpatients Assess the frequency and severity of adverse events related to the treatment with naloxone, such as increased posictal pain and/or early recurrence of GCTS. ;Primary end point(s): Proportion of patients whose oxygen saturation (SpO2) is <90% during at least 5 seconds between 30 seconds and 5 minutes after onset of intravenous injection of the study drug in the immediate aftermath of a GTCS ;Timepoint(s) of evaluation of this end point: 5 minutes	—

Measure

Time frame

Main Objective: The main objective of the study is to evaluate the efficacy of 0.4 mg intravenous naloxone, versus placebo, administered in the immediate aftermath of a GTCS, in reducing the severity of the postictal central respiratory dysfunction occurring after the end of the seizure, as measured by pulse oximetry.;Secondary Objective: Assess the impact of naloxone on respiratory parameters such as the frequency of apneas (> 10 seconds) occurring after the end of the seizure. Assess the impact of naloxone on 02 administration requirement and on cardiorespiratory rescue procedure requirement after the end of the seizure. Assess the impact of naloxone on the postictal generalized EEG suppression, the duration of which is correlated with the risk of SUDEP, and the severity of which could also result from a seizure-related release of endogenous opioids. Assess the impact of naloxone on the duration of the postictal coma following a GTCS, and the time required by the patient to recover preictal clinical condition. In the future, this clinical benefit might be enough significant to justify the systematic use of naloxone after GTCS in inpatients Assess the frequency and severity of adverse events related to the treatment with naloxone, such as increased posictal pain and/or early recurrence of GCTS. ;Primary end point(s): Proportion of patients whose oxygen saturation (SpO2) is <90% during at least 5 seconds between 30 seconds and 5 minutes after onset of intravenous injection of the study drug in the immediate aftermath of a GTCS ;Timepoint(s) of evaluation of this end point: 5 minutes

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Secondary

Measure	Time frame
Secondary end point(s): -Other respiratory parameters -Proportion of patients whose SpO2 is 10 seconds between 30 seconds and 5 minutes after onset of intravenous injection of the study drug in the immediate aftermath of a GTCS. -Number of patients in whom 02 administration is required within the ten minutes following the end of a GTCS. -Number of patients in whom cardiorespiratory rescue procedure is required within the ten minutes following the end of a GTCS -Total duration of the postictal generalized EEG suppression, defined as lack of detectable EEG activity >10 mV in amplitude on all leads. -Total duration of the postictal coma, defined as the delay between the end of the seizure and the recovery of consciousness assessed by the ability to meet one single verbal command (handshake). -Report of adverse events observed throughout the study -Assessment of pain, using a visual analog scale, immediately after the recovery of consciousness following the postictal coma. -Number of patients who have a second GCTS within 120 minutes after the intravenous injection. ;Timepoint(s) of evaluation of this end point: 120 minutes	—

Measure

Time frame

Secondary end point(s): -Other respiratory parameters -Proportion of patients whose SpO2 is 10 seconds between 30 seconds and 5 minutes after onset of intravenous injection of the study drug in the immediate aftermath of a GTCS. -Number of patients in whom 02 administration is required within the ten minutes following the end of a GTCS. -Number of patients in whom cardiorespiratory rescue procedure is required within the ten minutes following the end of a GTCS -Total duration of the postictal generalized EEG suppression, defined as lack of detectable EEG activity >10 mV in amplitude on all leads. -Total duration of the postictal coma, defined as the delay between the end of the seizure and the recovery of consciousness assessed by the ability to meet one single verbal command (handshake). -Report of adverse events observed throughout the study -Assessment of pain, using a visual analog scale, immediately after the recovery of consciousness following the postictal coma. -Number of patients who have a second GCTS within 120 minutes after the intravenous injection. ;Timepoint(s) of evaluation of this end point: 120 minutes

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Countries

France

Contacts

Public ContactZUBLENA

HOSPICES CIVILS DE LYON

irene.zublen@chu-lyon.fr04 72 40 68 46

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026