This is an observational study of all women with a diagnosis of LEMS who may or may not have been exposed to FIRDAPSE during pregnancy. In order to better describe the safety profile of FIRDAPSE when used during pregnancy, and in alignment with the FDA, Catalyst is conducting a pregnancy program to collect and evaluate the effect of FIRDAPSE on maternal pregnancy complications and outcomes, and on the health of infants exposed during pregnancy. The lack of data on human pregnancy exposures to FIRDAPSE makes such a study an essential component of the ongoing program of pharmacoepidemiological studies on the safety of this product. The success of the study is dependent upon the participation of eligible patients and healthcare providers. Thank you for your time and consideration.
To enroll a patient or to request additional information:
If a patient is eligible for participation, she will be asked to verbally consent to details about the registry and to collect personal health information from healthcare providers involved in the care of her pregnancy and that of her infant.
Your patient's participation in the pregnancy registry may last throughout her pregnancy and up to one year after her delivery date. Your patient will be contacted once per trimester, at the estimated date of delivery, and when her infant is 3, 6, 9, and 12 months of age to provide basic information about her pregnancy, post pregnancy health and her infant's health. At each time point your patient will be asked to confirm her contact information.
A healthcare provider's participation will vary depending on if they are treating the patient or infant. The woman's obstetric HCP will be contacted between the 6th and 7th month of the patient's pregnancy and, again for the prenatal testing information within 4 weeks after the estimated delivery date. The pediatric HCP will be contacted when the baby is approximately 3, 6, 9, and 12 months old. In order to collect the information, The Pregnancy Coordinating Center will send questionnaires to the appropriate HCP for completion.
The Pregnancy Coordinating Center is responsible for collecting the study data. All data provided by you and/or your patient will be entered into the study database. The study database will be kept on a secure computer system maintained by the study administrator in accordance with their written security policy. Information about your health collected while you are in the FIRDAPSE Pregnancy Registry will be kept anonymous and any identifying information will not be used.
The success of the FIRDAPSE Pregnancy Registry depends on the continued participation of healthcare providers like you. We greatly appreciate your help with identifying and enrolling patients in the study, and in assisting with the collection of follow-up information during your patient's participation in the study.