TerminatedPhase 1/2

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

Stopped: Company Decision

Australia20 participantsStarted 2021-01-01

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Completed the DA07976 or CLN100P.01 Study
✓. 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.
✓. Subject is taking currently approved AED medication(s) (but is not on valproate or divalproex sodium).
✓. Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the Investigator, by the subject or caregiver.
✓. 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.
✓. Subject understands study procedures and has voluntarily provided signed, informed consent in accordance with institutional and local regulatory requirements.
✓. Needs be literate in English or native language of the country of the study enrollment to complete neuropsychological testing.
✓. Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual.

Safety measured as drug or device related SAEs

Timeframe: 2-years

NCT IDNCT04529954

SponsorCerebral Therapeutics LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-01

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Completed the DA07976 or CLN100P.01 Study
✓. 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.
✓. Subject is taking currently approved AED medication(s) (but is not on valproate or divalproex sodium).
✓. Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the Investigator, by the subject or caregiver.
✓. 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.
✓. Subject understands study procedures and has voluntarily provided signed, informed consent in accordance with institutional and local regulatory requirements.
✓. Needs be literate in English or native language of the country of the study enrollment to complete neuropsychological testing.
✓. Subject can be reasonably expected to maintain a seizure diary alone or with the assistance of a competent individual.