Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorUniversity of Pittsburgh
About this trial
This project focuses on anti-seizure medication (ASM) clearance and physiological factors determining blood concentrations in pregnant adult women with epilepsy and amounts of exposure to their unborn children and nursing infants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Woman with epilepsy between the ages of 18-45 planning pregnancy or in the early first trimester of pregnancy.
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)
Disqualifiers
Women with epilepsy having history of functional seizures.
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).
Trial population
Participants to be mainly recruited from Neurology and OBGYN clinics.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Lamotrigine
DrugAnti-seizure concentrations
Levetiracetam
DrugAnti-seizure concentrations
Oxcarbazepine
DrugAnti-seizure concentrations
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Lamotrigine (LTG)1 intervention
Group B: Levetiracetam (LEV)1 intervention
Group C: Oxcarbazepine (OXC)1 intervention
Trial outcomes
Primary outcomes
1
Anti-Seizure Medication (ASM) Clearance
ASM Clearance will be calculated from measurements of lamotrigine, oxcarbazepine, and levetiracetam blood concentrations, serum creatinine and 24-hour urine collection (for levetiracetam), glucuronidated metabolite (for lamotrigine), steroid hormones, medication formulation and doses, time since recent doses, and participant weight.
Time frame
Through study completion, an average of 18 months.Secondary outcomes
1
Seizure Frequency
Participants will keep a daily seizure diary throughout their participation in the study. The diary will be reviewed at each study visit.
Time frame
Through study completion, an average of 18 months.2
Anti-seizure Medication (ASM) Side Effects
An ASM Side Effect Questionnaire will be administered and a neurologic examination will be performed at each study visit.
Time frame
Through study completion, an average of 18 months3
Placental passage of Anti-Seizure Medications (ASM)
Maternal blood will be drawn and umbilical cord blood will be collected, for measurements of ASM concentrations for lamotrigine, oxcarbazepine, and levetiracetam.
Time frame
Through study completion, an average of 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov