NCT02556320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 25, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

September 18, 2015

Last Update Submit

January 22, 2016

Conditions

EpilepsyDrug Hypersensitivity Syndrome

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Secondary Outcomes (1)

  • Change from baseline in lymphocyte population count

    3 Months

Study Arms (1)

Epileptic patient

EXPERIMENTAL

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

Drug: anti-epileptic drugBiological: Blood sampling

Interventions

anti-epileptic drugDRUG

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

Epileptic patient
Blood samplingBIOLOGICAL

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

Epileptic patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, 76031, France

Location

MeSH Terms

Conditions

EpilepsyDrug Hypersensitivity Syndrome

Interventions

AnticonvulsantsBlood Specimen Collection

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesDrug EruptionsDermatitisSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesDrug HypersensitivityDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Central Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Sophie DUVERT-LEHEMBRE, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 22, 2015

Study Start

May 1, 2013

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

January 25, 2016

Record last verified: 2016-01

Locations

FR(1)