Pharmacokinetic and Placental Transfer of Levetiracetam

Pharmacokinetic and Placental Transfer of Levetiracetam - EPICEINTE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004878-22-FR

Enrollment

Registered

2020-12-03

Start date

2021-01-12

Completion date

Unknown

Last updated

2023-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy in pregnancy MedDRA version: 21.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders

Interventions

Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LEVETIRACETAM CAS Number: 102767-28-2

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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 - Explain the interindividual variability of maternal pharmacokinetics and transplacental passage of Levetiracetam. - Link the concentration and its variation in the individual to the effects of treatment ;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	—

Measure

Time frame

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 - Explain the interindividual variability of maternal pharmacokinetics and transplacental passage of Levetiracetam. - Link the concentration and its variation in the individual to the effects of treatment ;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

Measure	Time frame
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). 2) Exposure ratio 3) Link between levetiracetam concentrations and effects: - 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). - tolerance: presence or absence of clinical and biological abnormalities occurring in pregnant women and children. ;Timepoint(s) of evaluation of this end point: 1) at inclusion , until 17 weeks, until 28 weeks and until 6 week after delivery 2) at delivery 3)at inclusion , until 17 weeks, until 28 weeks and until 6 week after delivery	—

Measure

Time frame

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). 2) Exposure ratio 3) Link between levetiracetam concentrations and effects: - 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). - tolerance: presence or absence of clinical and biological abnormalities occurring in pregnant women and children. ;Timepoint(s) of evaluation of this end point: 1) at inclusion , until 17 weeks, until 28 weeks and until 6 week after delivery 2) at delivery 3)at inclusion , until 17 weeks, until 28 weeks and until 6 week after delivery

—

Countries

France

Contacts

Public ContactDRCI, Hôpital St Louis

ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS

alexandra.bruneau@aphp.fr33144841712

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026