Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs

NCT ID: NCT02556320

Last Updated: 2016-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2015-12-31

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.

Conditions

Epilepsy; Drug Hypersensitivity Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Epileptic patient

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

Group Type: EXPERIMENTAL

anti-epileptic drug

Intervention Type: DRUG

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

Blood sampling

Intervention Type: BIOLOGICAL

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

Interventions

anti-epileptic drug

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

Intervention Type: DRUG

Blood sampling

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

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sophie DUVERT-LEHEMBRE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Other Identifiers

2012/075/HP

Identifier Type: -

Identifier Source: org_study_id