Study of Predictors of Response to Anti Epilepsy in Epilepsy

NCT02883712 | Terminated

• 2 other identifiers: 2011_372012-A00916-37
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Seizure

Keywords

epilepsy; pharmacoresistant; antiepileptic drug; pharmacokinetic; pharmacodynamic; pharmacogenetic

Outcome Measures

Primary Outcomes (1)

• Clinical global impression of the patient

  Clinical global impression assessment

  3 months

Secondary Outcomes (7)

• Number of seizure

  3 months

• Quality of life

  3 months

• Adverse events

  3 months

• Concentration of the anti epileptic drug

  3 months

• Pharmacogenetics of the uridine 5'-diphosphate glucuronosyltransférases (UGT1A1, UGT2B7, UGT1A4)

  3 months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients referred to our center with epilepsy (pharmacoresistant or pharmacosensitive)

You may qualify if:

• Epileptic patients who required a treatment adaptation

You may not qualify if:

• patients unable to give reliable information and without caregiver
• pregnancy
• Severe comorbidity, which would impede interpretation

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasmatic and serum samples for the dosage of the drugs Leucocytes for the intracellular dosage of the drugs DNA for pharmacogenetics analysis of the metabolism and pharmacodynamic targets of the drugs DNA for the genetic causes of epilepsy

MeSH Terms

Conditions

Seizures; Epilepsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• David DEVOS, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 30, 2016
• Study Start: May 21, 2013
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)