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NCT05450978 · ClinicalTrials.gov registry record
Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
A clinical trial of Epilepsy and Pregnancy Related, sponsored by University of Pittsburgh.
- Recruiting
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT05450978: Recruiting study of Epilepsy and Pregnancy Related, sponsored by University of Pittsburgh.
NCT05450978 is a study of Epilepsy and Pregnancy Related that is actively recruiting participants, run by University of Pittsburgh. The registered enrollment target is 60 participants, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05450978, a study of Epilepsy and Pregnancy Related, is actively recruiting participants, sponsored by University of Pittsburgh.
- RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Lamotrigine
- DRUG Levetiracetam
- DRUG Oxcarbazepine
Study Locations (1)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-07-20 |
| Est. Completion | 2028-04-01 |
What NCT05450978 shows while recruiting
NCT05450978 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 952-participant average among 160 other Epilepsy trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Epilepsy appearing as the primary indexed condition, and to 3 interventions - of which Lamotrigine is the first listed.
NCT05450978 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05450978 about?
NCT05450978 is a clinical study titled "Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding". 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.
What is the current status of trial NCT05450978?
This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2022-07-20. Estimated completion is 2028-04-01.
What conditions does trial NCT05450978 study?
This clinical trial studies the following conditions: Epilepsy, Pregnancy Related.
What interventions are being tested in trial NCT05450978?
The interventions under investigation include: Lamotrigine (DRUG), Levetiracetam (DRUG), Oxcarbazepine (DRUG).
Who is sponsoring clinical trial NCT05450978?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05450978 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05450978's enrollment target sits among peer trials
60 78th of 160 higher than 78 of 160 other Epilepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epilepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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