ACTRN12622001121752
Recruiting
未知
A multicenter, open-label, longitudinal, prospective, pharmacokinetic phase 1b study in pregnant women with epilepsy treated with lacosamide: a substudy of the the Australian Pregnancy Register of Antiepileptic Drugs for Women in Pregnancy with Epilepsy and Allied Conditions.
Melbourne Health trading as The Royal Melbourne Hospital0 sites30 target enrollmentAugust 15, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- Melbourne Health trading as The Royal Melbourne Hospital
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
Not specified
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