Epilepsy Clinical Trial
Official title:
Therapeutic Drug Monitoring of New Generation Antiepileptic Drugs: Concrete Benefit, Correlation With Clinical Effects and Usefulness of Saliva Samples
NCT number | NCT02739282 |
Other study ID # | 2015-00079 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | January 8, 2019 |
Verified date | January 2019 |
Source | Centre Hospitalier Universitaire Vaudois |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 151 |
Est. completion date | January 8, 2019 |
Est. primary completion date | January 8, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - People with epilepsy - On newer generation antiepileptic drugs - Need to adjust the medication Exclusion Criteria: - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Switzerland | CHUV | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Dr Jan Novy |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival in the study, using a composite outcome | Composite endpoint (any of those): 2 seizures with impaired consciousness, status epilepticus (defined as any seizure lasting >5 minutes), need of an add-on antiepileptic drug, need to discontinue the study drug (lack of efficacy or adverse reactions) or hospital admission | 1 year | |
Secondary | Correlation between serum and salivary antiepileptic drug level | Statistical correlation and measure of Rsquare | 1 year |
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