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Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs (VIRIDAE)

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ClinicalTrials.gov Identifier: NCT02556320
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug Hypersensitivity Syndrome Drug: anti-epileptic drug Biological: Blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs
Study Start Date : May 2013
Actual Primary Completion Date : August 2015
Actual Study Completion Date : December 2015


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556320


Locations
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France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Sophie DUVERT-LEHEMBRE, MD Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT02556320     History of Changes
Other Study ID Numbers: 2012/075/HP
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Carbamazepine
Hypersensitivity
Drug Hypersensitivity
Drug Hypersensitivity Syndrome
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Drug Eruptions
Dermatitis
Skin Diseases
Lamotrigine
Valproic Acid
Eslicarbazepine acetate
Oxcarbazepine
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Sodium Channel Blockers
Enzyme Inhibitors
GABA Agents
Neurotransmitter Agents
Antimanic Agents
Analgesics, Non-Narcotic