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 个研究点目标入组 30 人开始时间: 2022年8月15日最近更新: 2024年7月15日

适应症

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•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.

•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.

发起方

Melbourne Health trading as The Royal Melbourne Hospital