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

Inclusion Criteria

• •1. Completed the DA07976 or CLN100P.01 Study
• •2. In the opinion of the investigator, if the subject were to be removed from study and associated therapy, subject would have worsening/increase in disabling seizures. Disabling refers to seizures that are severe enough to cause injuries, or significantly impair functional ability in domains including employment, psychosocial education and mobility.
• •3. Subject is taking currently approved AED medication(s) (but is not on valproate or divalproex sodium).
• •4. Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the Investigator, by the subject or caregiver.
• •5. Subject has hearing, vision, and physical abilities adequate to perform assessments, with or without corrective aids, including keeping a seizure and medication diary during study follow-up.
• •6. Subject understands study procedures and has voluntarily provided signed, informed consent in accordance with institutional and local regulatory requirements.
• •7. Needs be literate in English or native language of the country of the study enrollment to complete neuropsychological testing.
• •8. Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual.
• •9. Women of childbearing potential must be using a medically accepted method of contraception and have a negative qualitative β-human chorionic growth hormone (β-HCG) pregnancy test result from a urine or blood sample collected per SOE.