Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Diagnostic
  • Masking: None (Open Label)
• Study Primary Completion Date: August 2015

Interventions

• Drug: anti-epileptic drug
  • Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)
• Biological: Blood sampling
  • Blood sampling is done for Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University Hospital, Rouen
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Sophie DUVERT-LEHEMBRE, MD, Principal Investigator, Rouen University Hospital