Trial · NCT05450978
Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
NCT05450978, Recruiting, University of Pittsburgh
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding. Trials, record NCT05450978. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05450978
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
- NCT number
- NCT05450978
- Status
- Recruiting
- Enrollment
- 60 participants, estimated
- Lead sponsor
- University of Pittsburgh
- Conditions
- Epilepsy, Pregnancy Related
- Interventions
- Lamotrigine, Levetiracetam, Oxcarbazepine
- First posted
- 2022-07-11
- Last updated
- 2026-05-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anti-Seizure Medication (ASM) Clearance | Through study completion, an average of 18 months. | 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. |
| Secondary | Seizure Frequency | Through study completion, an average of 18 months. | Participants will keep a daily seizure diary throughout their participation in the study. The diary will be reviewed at each study visit. |
| Secondary | Anti-seizure Medication (ASM) Side Effects | Through study completion, an average of 18 months | An ASM Side Effect Questionnaire will be administered and a neurologic examination will be performed at each study visit. |
| Secondary | Placental passage of Anti-Seizure Medications (ASM) | Through study completion, an average of 18 months | Maternal blood will be drawn and umbilical cord blood will be collected, for measurements of ASM concentrations for lamotrigine, oxcarbazepine, and levetiracetam. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01HD105305 | Physiological-based Pharmacokinetics Approach to Determine the Extent of Drug Exposure of Antiseizure Medications During Pregnancy and Breastfeeding | BIRNBAUM, ANGELA K; PENNELL, PAGE BUCKHANNAN | UNIVERSITY OF MINNESOTA | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2021 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05450978
GET https://conductscience.org/api/trials/v1/NCT05450978/registered