Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
NCT ID: NCT05450978
Last Updated: 2025-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
60 participants
OBSERVATIONAL
2022-07-20
2028-04-01
Brief Summary
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Detailed Description
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1. Adjust doses in practice without obtaining frequent visits to the lab for therapeutic drug monitoring.
2. Predict exposure of ASMs in mothers and their infants in order to maintain the individualized target concentrations, thus protecting mothers from seizure worsening and minimizing fetal toxicity.
Hypotheses:
1. Drug concentrations obtained in preconception and early pregnancy predict clearance changes throughout the remainder of pregnancy for individual pregnant women with epilepsy.
2. Validated model allows the prediction of drug concentration changes at all stages throughout and after pregnancy, which will more accurately predict increased seizures and medication side effects.
Additionally, pilot data will be obtained for oxcarbazepine (OXC) in a small number of participants and contribute to data for ASMs that undergo glucuronidation (LTG).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lamotrigine (LTG)
Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with lamotrigine (LTG)
Lamotrigine
Anti-seizure concentrations
Levetiracetam (LEV)
Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with Levetiracetam (LEV)
Levetiracetam
Anti-seizure concentrations
Oxcarbazepine (OXC)
Participants will include women with epilepsy planning pregnancy or in the early first trimester of pregnancy and treated with with Oxcarbazepine (OXC)
Oxcarbazepine
Anti-seizure concentrations
Interventions
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Lamotrigine
Anti-seizure concentrations
Levetiracetam
Anti-seizure concentrations
Oxcarbazepine
Anti-seizure concentrations
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women with epilepsy ability to maintain a daily medical diary
* Women with epilepsy ability to answer side effect questionnaires
* Women with epilepsy currently being treated with lamotrigine (LTG) or levetiracetam (LEV) or oxcarbazepine (OXC)
Exclusion Criteria
* Women with epilepsy history of other major medical illnesses including renal or hepatic disease, progressive cerebral disease,
* Women with epilepsy who have inability to maintain a seizure and medication daily diary
* Women with epilepsy with present or recent history of drug or alcohol abuse, or the use of any concomitant medications that interact with the ASM they are taking (lamotrigine, levetiracetam, oxcarbazepine).
18 Years
45 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Page B. Pennell, MD
Professor
Principal Investigators
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Page B Pennell, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Pittsburgh
Locations
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University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Pennell PB, French JA, May RC, Gerard E, Kalayjian L, Penovich P, Gedzelman E, Cavitt J, Hwang S, Pack AM, Sam M, Miller JW, Wilson SH, Brown C, Birnbaum AK, Meador KJ; MONEAD Study Group. Changes in Seizure Frequency and Antiepileptic Therapy during Pregnancy. N Engl J Med. 2020 Dec 24;383(26):2547-2556. doi: 10.1056/NEJMoa2008663.
Birnbaum AK, Meador KJ, Karanam A, Brown C, May RC, Gerard EE, Gedzelman ER, Penovich PE, Kalayjian LA, Cavitt J, Pack AM, Miller JW, Stowe ZN, Pennell PB; MONEAD Investigator Group. Antiepileptic Drug Exposure in Infants of Breastfeeding Mothers With Epilepsy. JAMA Neurol. 2020 Apr 1;77(4):441-450. doi: 10.1001/jamaneurol.2019.4443.
Pennell PB, Karanam A, Meador KJ, Gerard E, Kalayjian L, Penovich P, Matthews A, McElrath TM, Birnbaum AK; MONEAD Study Group. Antiseizure Medication Concentrations During Pregnancy: Results From the Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) Study. JAMA Neurol. 2022 Apr 1;79(4):370-379. doi: 10.1001/jamaneurol.2021.5487.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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STUDY21090138
Identifier Type: -
Identifier Source: org_study_id
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