Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs (NCT02556320) | Clinical Trial Compass
CompletedNot Applicable
Immunological and Viral Parameters in Patients Receiving Anti-epileptic Drugs
France30 participantsStarted 2013-05
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients with viral reactivation of Epstein-Barr Virus
Timeframe: 3 Months
2
Number of patients with viral reactivation of Human Herpes Virus 6
Timeframe: 3 Months
3
Number of patients with viral reactivation of Human Herpes Virus 7