Study of Predictors of Response to Anti Epilepsy in Epilepsy

Seizure Clinical Trial

— RESISTANT  

Official title:

Study of Predictors of Response to Anti Epilepsy in Epilepsy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02883712
• Other study ID #: 2011_37
• Secondary ID: 2012-A00916-37
• Status: Terminated
• 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
• 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

Related Conditions & MeSH terms

• Epilepsy
• Seizure
• Seizures

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