Expanded Access Program for Treatment with LP352 for Patients with Developmental and Epileptic Encephalopathies [DEEs] (NCT06149663)

The purpose of this Expanded Access Program (EAP) is to provide continued access to LP352, an Investigational Medicinal Product (IMP), which has no marketing authorisations anywhere in the world and which is being investigated in patients with Developmental and Epileptic Encephalopathies (DEEs). Within Australia, the EAP will; allow participants of LP352-201 and LP352-202 (approved by CHQ HREC, QCH lead site) to continue to access this treatment after the participant has successfully completed the LP352-202 trial (rollover patient), or provide treatment for an immediate family member of a participant that completed the LP352-202 trial who has the exact same gene mutation resulting in the same DEE phenotype (nave participant).

Trial phase

Other

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Terence O'Brien

Key inclusion data

Patient with DEE who has successfully completed an LP352 Clinical Trial (LP352-202 or LP352- 104); Patient currently has clinical benefit from LP352 treatment, as assessed by their Treating Physician; Patient currently tolerates LP352 treatment and has no safety issue which would prevent continued treatment.