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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02883712
Other study ID # 2011_37
Secondary ID 2012-A00916-37
Status Terminated
Phase
First received
Last updated
Start date May 21, 2013
Est. completion date January 2021

Study information

Verified date March 2021
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pharmacoresistant epilepsy remains around 30% despite the development of 25 anti epileptic drugs. Of course, this can be explained by pharmacoresistant epileptic brain diseases, as exemplified by some genetic diseases. However, the lack of specific guidelines for the choice of the anti epileptic drugs (apart from generalized and partial epilepsy) and the very large number of drugs with different and sometimes complex metabolism are challenges for neurologists. Among the 30 % of pharmacoresistant epilepsy, there is a part related to pharmacokinetic drawbacks that could be overcome with a more rigorous approach (i.e. dosage and pharmacogenetics tools). Moreover, the new anti epileptic drugs have metabolism more unrelated with the cytochrome P450 and less generalised adverse events. However, their metabolism could be more complexe (i.e. the less known Uridine 5'-diphospho-glucuronyltransferase (UGT) pathway) and bring more insidious neurological adverse events (i.e. depression, anxiety exacerbation, cognitive disorders worsening) which could largely impede the observance and the quality of life even if the number of seizure is reduced or not. The goal is to determine the predictive and the modulating factors of pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a specific analysis (drug by drug) from a cohort of 1000 patients.


Description:

The goal is to determine the predictive and the modulating factors of pharmacoresistance with a global analysis (i.e. whatever the anti epileptic drugs) and with a specific analysis (drug by drug with their specific metabolism pathways) from a cohort of 1000 patients. The response to the antiepileptic drugs modification will be analyse 3 months after the modification, with the analysis of the number of seizures, the quality of life, the Clinical Global Impression, the adverse events, the systematic dosage of all the molecules (residual concentration just before the taken) and the pharmacogenetic analysis of the main metabolism pathways and the main pharmacodynamic targets.


Recruitment information / eligibility

Status Terminated
Enrollment 155
Est. completion date January 2021
Est. primary completion date January 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Epileptic patients who required a treatment adaptation Exclusion Criteria: - patients unable to give reliable information and without caregiver - pregnancy - Severe comorbidity, which would impede interpretation

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital Roger Salengro, CHRU de Lille Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical global impression of the patient Clinical global impression assessment 3 months
Secondary Number of seizure recorded on the agenda of patients 3 months
Secondary Quality of life Analyse with the Quality Of Life In Epilepsy Questionnaire 3 months
Secondary Adverse events reported by the patients with a particular attention to attention and concentration worsening on interview 3 months
Secondary Concentration of the anti epileptic drug plasmatic drug concentration will be systematically 3 months
Secondary Pharmacogenetics of the uridine 5'-diphosphate glucuronosyltransférases (UGT1A1, UGT2B7, UGT1A4) the metabolism pathways of the drug 3 months
Secondary Pharmacogenetics of the Cytochrome P450 (2D6, 2C9, 2C19) the metabolism pathways of the drug 3 months
Secondary Depression inventory for epilepsy Neurological Disorders Depression Inventory for Epilepsy 3 months
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