RECRUITING

Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding

Talk to us

Conditions

EpilepsyPregnancy Related

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding

Quick Facts

Study Start:2022-07-20
Study Completion:2026-05-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05450978

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women planning pregnancy within the next 6 months.
  2. * Women currently being treated with lamotrigine (LTG) or levetiracetam (LEV) for a diagnosis of epilepsy
  1. * History of psychogenic non-epileptic spells
  2. * History of other major medical illnesses including renal or hepatic disease, progressive cerebral disease,
  3. * Inability to maintain a seizure and medication daily diary
  4. * 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 or levetiracetam).

Contacts and Locations

Study Contact

Tonge Ebai, PhD
CONTACT
4126160730
toe15@pitt.edu
Erica Kemp, PA
CONTACT
kempe2@upmc.edu

Principal Investigator

Page B Pennell, MD
PRINCIPAL_INVESTIGATOR
The University of Pittsburgh

Study Locations (Sites)

Kaufmann Medical Building
Pittsburgh, Pennsylvania, 15213
United States

Collaborators and Investigators

Sponsor: Page B. Pennell, MD

  • Page B Pennell, MD, PRINCIPAL_INVESTIGATOR, The University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-20
Study Completion Date2026-05-21

Study Record Updates

Study Start Date2022-07-20
Study Completion Date2026-05-21

Terms related to this study

Additional Relevant MeSH Terms

  • Epilepsy
  • Pregnancy Related