Therapeutic Drug Monitoring of New Generation Antiepileptic Drugs

NCT02739282 | Completed DMC

• 1 other identifier: 2015-00079
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief 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

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation between serum and salivary antiepileptic drug level

  1 year

Study Arms (2)

Systematic therapeutic drug monitoring

ACTIVE COMPARATOR

"Systematic therapeutic drug monitoring" performed at each clinic consultation and automatically transmitted to the clinician will be compared with clinically required therapeutic drug monitoring ("rescue therapeutic drug monitoring", transmitted only in case of predefined inefficacy or tolerance problems, as defined in the combine endpoint below), to assess if systematic therapeutic drug monitoring can prevent a proportion of treatment failure or adverse events.

Other: Systematic therapeutic drug monitoring

"Rescue" therapeutic drug monitoring

NO INTERVENTION

In the "rescue therapeutic drug monitoring" arm, communication of levels results will only be provided if a study endpoint (treatment failure or side effect as discussed below) is reached.

Interventions

Systematic therapeutic drug monitoring OTHER

Blood samples with antiepileptic drug level measurement

Systematic therapeutic drug monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People with epilepsy
• On newer generation antiepileptic drugs
• Need to adjust the medication

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Dr Jan Novy: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jan Novy, MD, PhD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Médecin associé

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 15, 2016
• Study Start: June 1, 2016
• Primary Completion: January 8, 2019
• Study Completion: January 8, 2019
• Last Updated: January 8, 2019

Record last verified: 2019-01

Locations

CH (1)