Pharmacokinetic and Placental Transfer of Levetiracetam

Phase 1

• Conditions: Epilepsy in pregnancy; MedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-004878-22-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-03
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

- Pregnant women of childbearing age who are pregnant
- Age =18 years
- Women with epilepsy treated with levetiracetam in monotherapy or combination
- Affiliated to a social security scheme (or entitled)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Women treated with antiepileptics for pathology other than epilepsy
- Women treated with a combination of more than 3 antiepileptics
- Severe anemia
- Renal failure (moderate to severe)
- Hepatic impairment (moderate to severe)
- Alcohol and/or recreational drug use
- Trend towards non-compliance with treatment
- Inability to maintain a Crisis Observation Workbook
- Suicidal Ideas
- Uncontrolled thyroid disease
- Woman under tutorship or curatorship
- Patient under state medical assistance (AME)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Objective: - Describe placental transfer during childbirth and during a medical termination of pregnancy<br>- Explain the interindividual variability of maternal pharmacokinetics and transplacental passage of Levetiracetam.<br> - Link the concentration and its variation in the individual to the effects of treatment<br>;Primary end point(s): Levetiracetam pharmacokinetics in pregnancy (Levetiracetam concentrations as a function of time);Timepoint(s) of evaluation of this end point: At delivery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Levetiracetam pharmacokinetics in pregnancy: Percentage of inter-individual variability in clearance or volume explained by a covariate (weight, serum creatinine, co-administration of other antiepileptics).<br>2) Exposure ratio<br>3) Link between levetiracetam concentrations and effects:<br>- correlate the evolution of the concentrations in the woman (value in the woman whose treatment is balanced before the pregnancy minus the value when she is pregnant) to the effectiveness (number of crises that the patient did).<br> - tolerance: presence or absence of clinical and biological abnormalities occurring in pregnant women and children.<br>;Timepoint(s) of evaluation of this end point: 1) at inclusion , until 17 weeks, until 28 weeks and until 6 week after delivery<br>2) at delivery <br>3)at inclusion , until 17 weeks, until 28 weeks and until 6 week after delivery