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Pharmacokinetic and Placental Transfer of Levetiracetam

NCT04117425 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-09-27

No results posted yet for this study

Summary

Hypotheses: The treatment of epilepsy during pregnancy is difficult because of the risk of anti-epileptic drugs on the one hand and the risk of destabilization of epilepsy in the mother on the other hand. There is limited data on the pharmacokinetics (concentration study) and pharmacodynamics (efficacy and toxicity effects study) of levetiracetam in pregnant women. The few studies focus on few women and show very strong interindividual variability and a tendency to decrease total concentrations.

Main objective: To develop a population pharmacokinetic model of levetiracetam during pregnancy. After the study, this model could be used to propose dose adjustments to maintain stable concentrations in pregnant women throughout pregnancy.

Secondary objectives:

* Describe placental transfer during childbirth and during a medical termination of pregnancy
* Link the concentration and its variation in the individual to the effects of treatment

Conditions

  • Epilepsy in Pregnancy

Interventions

BIOLOGICAL

biological collection

Blood collection at each trimester of pregnancy, delivery and post partum visit or at medical interruption. Collection of saliva at each trimester of pregnancy and post partum visit. Collection of cord blood and amniotic fluid at delivery or at medical interruption.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Jean Marc Tréluyer, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2023-06-30
Completion
2023-09-30

Countries

  • France

Study Locations

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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 NCT04117425 on ClinicalTrials.gov