Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

Epilepsy Clinical Trial

— VIRIDAE  

Official title:

Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556320
• Other study ID #: 2012/075/HP
• Status: Completed
• Phase: N/A
• First received: September 18, 2015
• Last updated: January 22, 2016
• Start date: May 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Drug Hypersensitivity Syndrome
• Epilepsy
• Hypersensitivity

Intervention

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)

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with viral reactivation of Epstein-Barr Virus	Number of patients with viral reactivation of Epstein-Barr Virus is evaluated in patients initiating an anti-epileptic treatment	3 Months	Yes
Primary	Number of patients with viral reactivation of Human Herpes Virus 6	Number of patients with viral reactivation of Human Herpes Virus 6 is evaluated in patients initiating an anti-epileptic treatment	3 Months	Yes
Primary	Number of patients with viral reactivation of Human Herpes Virus 7	Number of patients with viral reactivation of Human Herpes Virus 7 is evaluated in patients initiating an anti-epileptic treatment	3 Months	Yes
Secondary	Change from baseline in lymphocyte population count	Lymphocyte population count will be compared between baseline and 3 months after the treatment initiation	3 Months	No