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

Phase 1

• Conditions: Sudden unexpected death in epilepsy (SUDEP) primarily affects young adults with drug-resistant epilepsy; MedDRA version: 18.0Level: LLTClassification code 10065336Term: Partial epilepsySystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2014-003003-30-FR
• Lead Sponsor: HOSPICES CIVILS DE LYO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-18
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified