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

Recruiting

• Conditions: Epilepsy; Pregnancy Related

• Registration Number: NCT05450978
• Lead Sponsor: Page B. Pennell, MD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-6-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Inclusion Criteria:<br><br> - Women planning pregnancy within the next 6 months.<br><br> - Women currently being treated with lamotrigine (LTG) or levetiracetam (LEV) for a<br> diagnosis of epilepsy<br><br>Exclusion Criteria:<br><br> - History of psychogenic non-epileptic spells<br><br> - History of other major medical illnesses including renal or hepatic disease,<br> progressive cerebral disease,<br><br> - Inability to maintain a seizure and medication daily diary<br><br> - Present or recent history of drug or alcohol abuse, or the use of any concomitant<br> medications that interact with the ASM they are taking (lamotrigine or<br> levetiracetam).

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational [Patient Registry]
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anti-Seizure Medication (ASM) Clearance

Secondary Outcome Measures

Name	Time	Method
Seizure Frequency;Anti-seizure Medication (ASM) Side Effects;Placental passage of Anti-Seizure Medications (ASM)