Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

Not Applicable

Completed

• Conditions: Drug Hypersensitivity Syndrome; Epilepsy
• Interventions: Drug: anti-epileptic drug; Biological: Blood sampling

• Registration Number: NCT02556320
• Lead Sponsor: University Hospital, Rouen

Brief Summary

A recent study has shown that certain drug allergies were actually related to an immune system against certain viruses. The aim of the study is to evaluate, in patients taking antiepileptic drugs, if this treatment induces proliferation of these viruses and secondarily an immune response that would promote the development of a rash. In particular, will be studied whether these drugs can induce virus reactivation "dormant" in the immune system. This study will not affect the usual follow-up proposed by investigators, with the exception of some additional blood samples.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2015-08
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients age over 18 years
• Patient for whom treatment of antiepileptic class will be started or was set for less than 48 hours and including one of the following molecules (as princeps or generic equivalent form): sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine eslicarbazepine acetate.
• Patient or patient's representative who was informed and signed the consent form
• Effective contraception in women of childbearing age
• Affiliation to health insurance

Exclusion Criteria

• Immunosuppressive therapy in progress or acquired immunodeficiency
• Patient with meningitis or meningoencephalitis
• Patient with known contraindications to any molecules indicated in the study
• Major Patient protection (guardianship) or deprived of liberty by judicial or administrative decision.
• Patient participating in another clinical trial or participated in another trial in the month before.
• Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epileptic patient	Blood sampling	Blood sampling is done for Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)
Epileptic patient	anti-epileptic drug	Blood sampling is done for Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)

Primary Outcome Measures

Name	Time	Method
Number of patients with viral reactivation of Epstein-Barr Virus	3 Months	Number of patients with viral reactivation of Epstein-Barr Virus is evaluated in patients initiating an anti-epileptic treatment
Number of patients with viral reactivation of Human Herpes Virus 6	3 Months	Number of patients with viral reactivation of Human Herpes Virus 6 is evaluated in patients initiating an anti-epileptic treatment
Number of patients with viral reactivation of Human Herpes Virus 7	3 Months	Number of patients with viral reactivation of Human Herpes Virus 7 is evaluated in patients initiating an anti-epileptic treatment

Secondary Outcome Measures

Name	Time	Method
Change from baseline in lymphocyte population count	3 Months	Lymphocyte population count will be compared between baseline and 3 months after the treatment initiation

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France