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OpenTrials
Completed

NCT Number: NCT02556320

Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

anti-epileptic drug

Drug

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

Blood sampling

Biological

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

Primary outcomes

  1. 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

  2. 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

  3. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: VIRIDAE

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 22, 2015
Registry last updated
Jan 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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