A Dose Ranging Pilot Study for Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Temporal Seizures
Status:
Completed
Trial end date:
2021-06-01
Target enrollment:
Participant gender:
Summary
Patients with medically refractory epilepsy will be treated by intracerebroventricular (ICV)
delivery of valproate using an implantable drug pump system. The dose of valproate will be
escalated weekly during a blinded-evaluation period through Day 64 to determine the maximum
tolerated dose (MTD). After Day 64, patients can continue for 52 weeks in the open-label
evaluation period (non-blinded). .