CompletedNot Applicable

Pharmacokinetic and Placental Transfer of Levetiracetam

France14 participantsStarted 2022-04-20

Plain-language 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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Levetiracetam pharmacokinetics in pregnancy

Timeframe: At delivery

Trial details

NCT IDNCT04117425

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-16

View on ClinicalTrials.gov More Epilepsy in Pregnancy trials