Clinical Trials Directory

Trials / Terminated

TerminatedNCT04529954

Anti-Epilepsy Medication Valproate Administered Via ICV Route and Catheters and Pumps for CSF Infusion

An Open-Label Extension Study to Investigate the Long-Term Safety, and Tolerability of Intracerebroventricular (ICV) Delivery of Valproate in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization

Status
Terminated
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Cerebral Therapeutics LLC · Industry
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

This is a non-randomized open-label extension study for subjects having completed protocol DA071976 or CLN100P.01.

Conditions

Interventions

TypeNameDescription
DRUGValproic Acid delivered to ICVValproic Acid delivered to ICV via an implantable pump and catheter system

Timeline

Start date
2021-01-01
Primary completion
2024-03-01
Completion
2024-03-01
First posted
2020-08-28
Last updated
2024-03-13

Locations

8 sites across 2 countries: Australia, Israel

Source: ClinicalTrials.gov record NCT04529954. Inclusion in this directory is not an endorsement.