This is a non-randomized open-label extension study for subjects having completed protocol DA071976 or CLN100P.01.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Valproic Acid delivered to ICV via an implantable pump and catheter system
Mater Brisbane
Brisbane, New South Wales, Australia
RBWH
Brisbane, New South Wales, Australia
SVHM
Melbourne, Victoria, Australia
The Alfred
Melbourne, Victoria, Australia
Safety measured as drug or device related SAEs
The primary objective is to assess long-term safety and tolerability of ICV delivery of Valproate as measured by drug and device related adverse events.
Time frame: 2-years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The Austin
Melbourne, Victoria, Australia
Hadassah Medical Center
Jerusalem, Israel
Sheeba Medical Center
Jerusalem, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel