None listed
Conditions
Brief summary
The objective of this Phase 1B, multicentre, longitudinal, prospective, PK, open label study is to assess any changes in LCM plasma concentrations that may result from physiological changes that occur during pregnancy in women with epilepsy. A change of PK during pregnancy will be assessed relative to postpartum LCM concentrations. In addition, if subjects give additional consent, this study will also measure LCM concentrations in mature breast-milk to estimate newborn LCM exposure. This collaborative study will be conducted as a sub-study of The Raoul Wallenberg Australian Pregnancy Register (RWAPR), which is an observational, prospective, longitudinal study of pregnancies in women taking ASMs, and also women with epilepsy not taking ASMs. The study is interventional due to the additional collection of blood samples and breast milk from women which are exceeding medical practice. However, all other study assessments are part of routine clinical practice, and any decision to continue/discontinue or change LCM therapy during pregnancy and breastfeeding will be made between the participant and her treating physician, taking into account potential risks and benefits, and according to the local label.
Interventions
The objective of this Phase 1B, multicentre, longitudinal, prospective, PK, open label study is to assess any changes in lacosamide plasma concentrations that may result from physiological changes that occur during pregnancy in women with epilepsy. A change of PK during pregnancy will be assessed relative to postpartum lacosamide concentrations. In addition, if subjects give additional consent, this study will also measure lacosamide concentrations in mature breast-milk to estimate newborn lac
The objective of this Phase 1B, multicentre, longitudinal, prospective, PK, open label study is to assess any changes in lacosamide plasma concentrations that may result from physiological changes that occur during pregnancy in women with epilepsy. A change of PK during pregnancy will be assessed relative to postpartum lacosamide concentrations. In addition, if subjects give additional consent, this study will also measure lacosamide concentrations in mature breast-milk to estimate newborn lacosamide exposure. The study is interventional due to the additional collection of blood samples and breast milk from women which are exceeding medical practice. Blood samples will be taken by local pathology centres at four time points: 0-14 weeks, 15-28 weeks and 29-40 weeks antenatal, and 6-12 weeks post-natal. The breast milk samples will be taken by a local pathology centre at 6-12 weeks post-natal. Medical, socioeconomic, lifestyle, medication and obstetric data will also be collected by 30-60 minute telephone interviews at these timepoints. All other study assessments are part of routine clinical practice, and any decision to continue/discontinue or change LCM therapy during pregnancy and breastfeeding will be made between the participant and her treating physician, taking into account potential risks and benefits, and according to the local label.
Sponsors
Melbourne Health trading as The Royal Melbourne Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed