Back to resultsImmunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs (VIRIDAE)
Primary Purpose
Epilepsy, Drug Hypersensitivity Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
anti-epileptic drug
Blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy
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.
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epileptic patient
Arm Description
Blood sampling is done for Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)
Outcomes
Primary Outcome Measures
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
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
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
Secondary Outcome Measures
Change from baseline in lymphocyte population count
Lymphocyte population count will be compared between baseline and 3 months after the treatment initiation
Full Information
NCT ID
NCT02556320
First Posted
September 18, 2015
Last Updated
January 22, 2016
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT02556320
Brief Title
Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs
Acronym
VIRIDAE
Official Title
Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Drug Hypersensitivity Syndrome
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epileptic patient
Arm Type
Experimental
Arm Description
Blood sampling is done for Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)
Intervention Type
Drug
Intervention Name(s)
anti-epileptic drug
Intervention Description
Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
Blood sampling is done for Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)
Primary Outcome Measure Information:
Title
Number of patients with viral reactivation of Epstein-Barr Virus
Description
Number of patients with viral reactivation of Epstein-Barr Virus is evaluated in patients initiating an anti-epileptic treatment
Time Frame
3 Months
Title
Number of patients with viral reactivation of Human Herpes Virus 6
Description
Number of patients with viral reactivation of Human Herpes Virus 6 is evaluated in patients initiating an anti-epileptic treatment
Time Frame
3 Months
Title
Number of patients with viral reactivation of Human Herpes Virus 7
Description
Number of patients with viral reactivation of Human Herpes Virus 7 is evaluated in patients initiating an anti-epileptic treatment
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Change from baseline in lymphocyte population count
Description
Lymphocyte population count will be compared between baseline and 3 months after the treatment initiation
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie DUVERT-LEHEMBRE, MD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
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Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs
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