acosamide pharmacokinetics changes in blood and breast mild during and after pregnancy

Not Applicable

Recruiting

• Conditions: Epilepsy; Neurological - Epilepsy

• Registration Number: ACTRN12622001121752
• Lead Sponsor: Melbourne Health trading as The Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-15
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

Age
1.Participant must be [18] to [50] years of age inclusive, at the time of signing the informed consent.
Type of participant and disease characteristics
2.Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
3.Participant must be considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the investigator.
4.Participant is currently treated with lacosamide as part their medical treatment.
5.Participant is a pregnant female.
6.Participant expects to continue lacosamide therapy throughout pregnancy and for at least 12 weeks postpartum.; Age
1.Participant must be [18] to [50] years of age inclusive, at the time of signing the informed consent.
Type of participant and disease characteristics
2.Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
3.Participant must be considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the investigator.
4.Participant is currently treated with lacosamide as part their medical treatment.
5.Participant is a pregnant female.
6.Participant expects to continue lacosamide therapy throughout pregnancy and for at least 12 weeks postpartum.

Exclusion Criteria

1.Women under age of 18 years at the time of signing the ICF.
2.Women with significant intellectual disability who, in the opinion of the investigator, are not able to understand the nature of the study.
3.Women with any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
4.Women with severe alterations of renal (ClCr <30 mL/min) and/or hepatic (liver function tests > 3x upper limit of normal) function.; 1.Women under age of 18 years at the time of signing the ICF.
2.Women with significant intellectual disability who, in the opinion of the investigator, are not able to understand the nature of the study.
3.Women with any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study.
4.Women with severe alterations of renal (ClCr <30 mL/min) and/or hepatic (liver function tests > 3x upper limit of normal) function.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome will be lacosamide plasma concentrations during pregnancy relative to the post-partum period.<br>[ 1. 0-14 weeks antenatal; 2. 15-28 weeks antenatal; 3. 29 weeks antenatal - delivery; 4. 6-12 weeks post-partum];Primary outcome will be lacosamide plasma concentrations during pregnancy relative to the post-partum period.<br>[ 1. 0-14 weeks antenatal; 2. 15-28 weeks antenatal; 3. 29 weeks antenatal - delivery; 4. 6-12 weeks post-partum]