A Dose Ranging Pilot Study for Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Temporal Seizures

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). .

Timeline

Start

2016-08

Primary completion

2021-06-01

Completion

2021-06-01

Publications

• Cook M, Murphy M, Bulluss K, D'Souza W, Plummer C, Priest E, Williams C, Sharan A, Fisher R, Pincus S, Distad E, Anchordoquy T, Abrams D. Anti-seizure therapy with a long-term, implanted intra-cerebroventricular delivery system for drug-resistant epilepsy: A first-in-man study. EClinicalMedicine. 2020 May 3;22:100326. doi: 10.1016/j.eclinm.2020.100326. eCollection 2020 May.

Drugs

Indications