Anti-Seizure Medications for Epilepsy During Pregnancy
(PBPK Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how anti-seizure medications (ASMs) such as Lamotrigine, Levetiracetam, and Oxcarbazepine are processed in the bodies of pregnant women with epilepsy, and how these drugs affect their unborn children and nursing infants. Researchers seek to identify factors that influence the levels of these medicines in the blood during pregnancy and breastfeeding. Women with epilepsy who are planning to become pregnant, are in the early stages of pregnancy, and are currently taking one of these medications might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding medication safety during pregnancy and breastfeeding.
Do I have to stop taking my current medications for the trial?
The trial requires that you continue taking your current anti-seizure medications, specifically lamotrigine, levetiracetam, or oxcarbazepine. However, you cannot take any other medications that interact with these drugs.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both lamotrigine and levetiracetam are safe during pregnancy. Studies involving thousands of pregnancies have found no increased risk of birth defects with lamotrigine, nor is it linked to developmental problems in children exposed to it before birth. This makes it a good choice for women needing seizure control while pregnant.
Levetiracetam has also undergone extensive research, with results indicating a low risk of major birth defects. It is classified as Pregnancy Category C, meaning the potential benefits may outweigh the risks. Both medications have demonstrated safety during pregnancy, effectively managing seizures without causing significant side effects to the baby.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it explores how medications like Lamotrigine and Levetiracetam are processed in the bodies of pregnant and breastfeeding women with epilepsy. Unlike typical studies that may not account for the unique physiological changes during pregnancy, this trial uses a physiological-based pharmacokinetics approach. This method aims to predict how these drugs are absorbed, distributed, metabolized, and excreted, offering a more tailored understanding of safe and effective medication use during these critical periods. By gaining insights into drug exposure, the trial could lead to better dosing recommendations, ultimately improving health outcomes for both mothers and their babies.
What evidence suggests that this trial's treatments could be effective for epilepsy in pregnant women?
This trial will compare the effects of different treatments for women with epilepsy who are planning pregnancy or are in the early first trimester. Research has shown that lamotrigine, one of the treatments in this trial, helps control seizures in pregnant women with epilepsy. Studies have found that using lamotrigine during pregnancy results in fewer negative pregnancy outcomes compared to some other seizure medications. Additionally, exposure to lamotrigine before birth does not seem to increase the risk of developmental issues in children.
Research confirms that levetiracetam, another treatment option in this trial, effectively manages epilepsy during pregnancy and does not significantly increase the risk of genetic disorders in newborns. It is also considered safe for pregnant women, as it generally does not cause serious birth defects. Both medications have strong research support for their safety and effectiveness during pregnancy.23567Who Is on the Research Team?
Page B Pennell, MD
Principal Investigator
The University of Pittsburgh
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive anti-seizure medications (ASM) and undergo pharmacokinetic monitoring during pregnancy and postpartum
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lamotrigine
- Levetiracetam
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with with Oxcarbazepine (OXC)
Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with Levetiracetam (LEV)
Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with lamotrigine (LTG)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
Page B. Pennell, MD
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
Seizure control and adverse outcomes of lamotrigine use ...
Regarding adverse pregnancy outcomes, the occurrence rate of LTG monotherapy was significantly lower than that of CBZ, VPA, phenytoin (PHT), and ...
Seizure control and adverse outcomes of lamotrigine use ...
This review aims to summarize existing evidence on the adverse pregnancy outcomes and seizure control effects of using lamotrigine (LTG) monotherapy in ...
3.
bmcpregnancychildbirth.biomedcentral.com
bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-023-06242-9Neurodevelopmental outcomes after prenatal exposure to ...
Prenatal exposure to lamotrigine monotherapy is not found to be statistically associated with neurodevelopmental disorders as a whole, language ...
Newer antiseizure drugs safe for pregnancy, Stanford ...
Two common antiseizure medications, lamotrigine and levetiracetam, are safe to use during pregnancy, according to a Stanford Medicine-led study.
Antiseizure medication use during pregnancy and ...
In cases where pregnant individuals have epilepsy, withdrawal of ASMs can lead to seizures, posing life-threatening risks to both the mother and ...
Lamotrigine (Lamictal®) - MotherToBaby | Fact Sheets - NCBI
Also, several studies looking at several thousand pregnancies have found no increased chance of birth defects when lamotrigine is taken during pregnancy. Does ...
Lamotrigine (Lamictal) Dosing During Pregnancy
Given its favorable reproductive safety profile, lamotrigine is a reasonable option for women who require treatment with a mood stabilizer during pregnancy.
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