A Dose Ranging Pilot Study to Assess Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization

NCT02899611 Phase 1/Phase 2 COMPLETED

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). .

Details

Lead sponsor	Cerebral Therapeutics LLC
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	6
Start date	2016-08
Completion	2021-06-01

Conditions

• Epilepsy

Interventions

• Valproate

Primary outcomes

• Maximum Tolerated Dose (MTD) — 2 months
  The ICV Valproate dose will be escalated stepwise through Day 64, if tolerated, or stopped earlier upon establishment of a subject's MTD. The MTD for each subject will be determined based on the highest dose tolerated without experiencing a dose-limiting AE.
• Safety: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] — 14 months
  Safety will be evaluated by monitoring for adverse events (AEs) and serious adverse events (SAEs). This will be monitored using various metrics including: clinical assessments, seizure diaries, concomitant medications, blood and CSF sampling. MRI Scan, EEG and ECG will also be performed and monitored to evaluate safety.
• Changes in the Number of Seizures — 14 months
  Seizure diaries will be collected, monitored and reviewed at designated time points.

Countries

Australia