Catalyst Pharmaceuticals, Inc., the manufacturer of FIRDAPSE® is conducting an observational program of women and infants exposed to at least one dose of FIRDAPSE during pregnancy. In addition, pregnancy and infant outcomes will be collected for pregnancies in women with LEMS who have not been exposed to FIRDAPSE. During the development of pharmaceutical products, pregnant women are typically excluded from clinical trials. Therefore, limited information is available on the use of FIRDAPSE during pregnancy. Information obtained from this study may assist health care providers and future pregnant women in weighing the risks and/or benefits of being treated with FIRDAPSE during pregnancy.
This is an observational study which means you will continue to receive care as decided by your healthcare provider(s). Your treatment or care will not change in any way as a result of your participation in this study.
Women exposed to at least one dose of FIRDAPSE during pregnancy;
Women with a diagnosis of LEMS during pregnancy who have not been exposed to FIRDAPSE while pregnant.
Your participation is voluntary but will provide important information that may eventually be used by healthcare providers and future patients when weighing the benefits and/or risks of taking FIRDAPSE during pregnancy. The success of the study is dependent upon the participation of eligible patients and healthcare providers. There will be no change to the care you receive by your healthcare provider, as this is an observational study. Thank you for your time and consideration.
BY PHONE-Call the FIRDAPSE Pregnancy Coordinating Center at
ONLINE-"Click" on the link to Report a Pregnancy
By providing your contact information, someone from the Pregnancy Coordinating Center will contact you to confirm necessary information to complete the registration. You may also ask your healthcare provider to enroll you.
If you are eligible and would like to participate, you will be asked to provide verbal informed consent to acknowledge your understanding of the study and to provide permission for your personal or infant's healthcare information to be collected. After consent is received, a study representative will send you a Medical Information Release (MIR) form to sign, date and return. This form gives our PCC permission to contact your healthcare provider to confirm your personal health information.Informed Consent Form (ICF) - U.S. Informed Consent Form (ICF) - Canada Medical Information
Your participation in the study may last throughout your pregnancy and up to one year after your delivery date. You will be contacted once per trimester, at the estimated date of delivery, and when your baby is 3, 6, 9, and 12 months of age to provide basic information about your pregnancy and your infant's health. At each time-point you will be asked to confirm your contact information.