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Cognitive Impact of Benzodiazepin Withdrawn After Curative Epilepsy Surgery in Children With Focal Epilepsy

NCT03803046 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1

Last updated 2021-03-26

No results posted yet for this study

Summary

Epilepsy is a frequent group of diseases, affecting 1% of the general population with a higher incidence in children. Anti-epileptic drugs are used as part of the drug treatment. Even if children with epilepsy have its own characteristics, as in adults, the choice of an anti-epileptic treatment is also based on the benefit-risk balance. The purpose of the treatment should not only be the seizure control. The occurence of side effects is a major factor to be taken into account. In the special populatIon of children with resistant epilepsy (20 to 30% of epilepsy), the treatment goal is not any more to be seizure free but to achieve the lowest possible frequency of seizures with the lowest level of side effects.

When assessing the benefit-risk balance of antiepileptic treatment, it is important to keep in mind that the child is a developing human being whose main activity is learning. Special attention should be paid to minimize treatments with excessive cognitive consequences. Be particularly wary of combination therapies (combinations of several antiepileptic treatments). Indeed, it is well established that they are more harmful than monotherapy. It is also important to avoid the use of drugs with too strong a cognitive effect. Some molecules such as phenobarbital or topiramate have been the subject of a few studies that have established their deleterious effect on the cognitive level. Among antiepileptics, benzodiazepines are sometimes used as disease-modifying therapy. In France, clobazam is the clonazepam have a Marketing Authorization for children.

However, there is no study to determine whether these molecules have cognitive consequences. In order to have more data to better establish the risk-benefit balance of benzodiazepines in the treatment of children with epilepsy, the investigators wish to conduct work to evaluate the cognitive consequences of benzodiazepines in children treated for epilepsy.

Conditions

  • Cognitive Impact of Antiepileptic Drugs

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Adina ILEA, Dr · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
6 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-09
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03803046 on ClinicalTrials.gov