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Therapeutic Drug Monitoring of New Generation Antiepileptic Drugs

NCT02739282 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2019-01-08

No results posted yet for this study

Summary

The investigators aim at studying therapeutic drug monitoring of newer generation antiepileptic drugs (AEDs) in people with epilepsy, using state of the art Ultra-performance Liquid Chromatography coupled to Tandem Mass Spectrometry:

* to assess the tangible benefit of individualising therapy through therapeutic drug monitoring in term of clinical response and adverse events
* to assess the reliability and added value of salivary therapeutic drug monitoring This will be assessed through a randomised trial of either systematic or rescue therapeutic drug monitoring in people requiring treatment adjustment; outcome will be assessed in term of tolerance and treatment response in a survival analysis to assess the benefit of systematic therapeutic drug monitoring. For each blood samples taken in those studies, a saliva probe will be collected and its reliability ascertained retrospectively.

Conditions

Interventions

OTHER

Systematic therapeutic drug monitoring

Blood samples with antiepileptic drug level measurement

Sponsors & Collaborators

  • Dr Jan Novy

    lead OTHER

Principal Investigators

  • Jan Novy, MD, PhD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2019-01-08
Completion
2019-01-08

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT02739282 on ClinicalTrials.gov