Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

Sponsors

Lead Sponsor: University Hospital, Rouen

Source 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.

Overall Status Completed
Start Date 2013-05-01
Completion Date 2015-12-01
Primary Completion Date 2015-08-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of patients with viral reactivation of Epstein-Barr Virus 3 Months
Number of patients with viral reactivation of Human Herpes Virus 6 3 Months
Number of patients with viral reactivation of Human Herpes Virus 7 3 Months
Secondary Outcome
Measure Time Frame
Change from baseline in lymphocyte population count 3 Months
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: anti-epileptic drug

Description: Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)

Arm Group Label: Epileptic patient

Intervention Type: Biological

Intervention Name: Blood sampling

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

Arm Group Label: Epileptic patient

Eligibility

Criteria:

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:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Sophie DUVERT-LEHEMBRE, MD Principal Investigator Rouen University Hospital
Location
Facility: Rouen University Hospital
Location Countries

France

Verification Date

2016-01-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Epileptic patient

Type: Experimental

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

Acronym VIRIDAE
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Diagnostic

Masking: None (Open Label)

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