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Pregnancy and epilepsy: scientists track how a key drug moves through the body

NCT ID NCT04117425

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This study looks at how the epilepsy drug levetiracetam is processed in pregnant women and how much reaches the baby. Researchers will collect blood and saliva samples throughout pregnancy and at delivery, plus cord blood and amniotic fluid. The goal is to create a model that could one day help doctors personalize doses to keep both mother and baby safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
levetiracetam
What this could lead to
If successful, this could help doctors adjust levetiracetam doses during pregnancy to keep seizure control stable while minimizing risks.
What could go wrong
This is a small observational study (14 participants) focused on measuring drug levels, not testing a new treatment. Results may not apply to all pregnant women with epilepsy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Epilepsy in pregnancy

Contacts and locations

Locations

  • hospital Cochin

    Paris, 75014, France