An Open Label Clinical Trial to Evaluate the Efficacy and Safety of PRAX-628 in Adult Patients with Focal Onset or Primary Generalized Tonic-Clonic Seizures (NCT06908356)

The main purpose of this study is to see how well PRAX-628 works in treating focal onset seizures (the type of seizure that starts when only one area of the brain starts firing uncontrolled electrical signals) and primary generalised tonic-clonic seizures (the type of seizure that occurs when uncontrolled electrical activity affects the entire brain from the start). Additional purposes of this study are to see how safe PRAX-628 is and how the body processes (pharmacokinetics, PK) it. In this study, all participants will receive PRAX-628 30 mg (3 x 10 mg capsules) once daily (QD) for 8 weeks.

Trial phase

Phase 2

Trial participation type

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

Principal investigator

Prof Terence O'Brien

Key inclusion data

Aged ?18 to ?75 years of age. A diagnosis of focal onset, focal onset to bilateral generalized, or primary generalized tonic clonic seizures according to the International League Against Epilepsy. Prior to enrollment, evidence by CT or MRI in the past that has ruled out a progressive cause of epilepsy.