About the EMBRAVE Study (Part 1)

Praxis is developing an antisense oligonucleotide (ASO) for the treatment of early-onset SCN2A Developmental and Epileptic Encephalopathy (DEE), currently referred to as PRAX-222. An ASO is a synthetic, short segment of genetic sequence that can be designed to selectively modulate a target gene expression to help restore its normal function.

Part 1 of the EMBRAVE study is designed to determine the safety and tolerability of PRAX-222 in the treatment of early-onset SCN2A DEE. In Part 1 of the study, all participants will receive PRAX-222 for up to 13 weeks.

It is important to note that PRAX-222 is an investigational drug, which means that it has not been approved for the treatment of SCN2A DEE by any regulatory or health authorities, including the U.S. Food and Drug Administration (FDA). Participation in clinical research studies is completely voluntary and you may end participation for your child at any time.

 

Children who meet the below Key Inclusion Criteria may be eligible to participate:

*          Resides in the United States of America

*          Documented SCN2A variant through genetic testing

*          Had seizure onset within the first 3 months of life.

*          Currently taking 2 or less sodium channel blocking anti-epileptic drugs.

**   Note: For the purposes of this clinical trial, sodium channel blocking ASMs will include carbamazepine, eslicarbazepine, lacosamide, lamotrigine, oxcarbazepine, phenytoin and rufinamide.

*          Male or female between the ages of ≥2 to ≤18 years of age

*         Has a minimum of 8 countable motor seizures 4 weeks prior to consenting to participate in the study AND a minimum of 8 countable motor seizures in the 4-week prior to the first dose of study medication

**   Note: Motor seizures are defined as tonic, tonic-clonic, atonic/drop attacks, focal

with secondary generalization, or focal with motor symptoms.

 

Schedule a call with a Nurse Patient Navigator

 

If you think your child may qualify for the PRAX-222 EMBRAVE study and would like to speak to a Nurse Patient Navigator to learn more, please schedule a pre-screening appointment by using the calendar function below.

 

If you don't think your child qualifies for the PRAX-222 EMBRAVE study, you may still schedule a call with a Nurse Patient Navigator to discuss your child's specific situation.

 

By checking this box, you consent to providing this information to Praxis Precision Medicines, Inc. (Praxis) and its employees, affiliates, and service providers. You understand that your information will be used to enable Praxis to engage in prescreening for the research study. You permit Praxis to share your information with third parties, including the Sites, Clinical Research Organizations, the Eligibility Review Board, and regulatory or public health agencies, in order to evaluate your eligibility for the research study.

Additionally, with this consent, Praxis will retain such information to provide you with updates, newsletters and communication related to Praxis’ ongoing studies and business updates.

Praxis will retain your personal data in accordance with its regulatory record keeping requirements or for as long as we have a legitimate legal or business need to do so. You understand that you can withdraw your consent at any time by contacting Privacy@praxismedicines.com. For more on our privacy practices and your privacy rights, including the right to withdraw your consent, please refer to our Privacy Policy at https://praxismedicines.com/privacy-policy/.

 



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