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

Primary Purpose

Focal Epilepsy

Status
Enrolling by invitation
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Valproic Acid delivered to ICV
Sponsored by
Cerebral Therapeutics LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Epilepsy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Completed the DA07976 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.

Exclusion Criteria:

  • 1. Subject has any significant neurologic disease other than epilepsy. 2. Subject has had status epilepticus refractory to benzodiazepines and phenytoin in the past year 3. Subject is currently taking oral valproic acid or sodium divalproex. 4. Subject has known allergy to valproic acid, divalproex sodium, Epilim, or Depacon.

    5. Subject has unstable depression or any major psychiatric disorder including psychosis, major depression, bipolar disorder that in the opinion of the Investigator would put the subject at risk as a participant in the study.

    6. Subject has history or evidence of congestive heart failure, clinically significant peripheral edema, or anemia with a hematocrit <30%.

    7. Subject has current diagnosis of cancer requiring treatment. 8. Subject in the opinion of the Investigator, is not a suitable candidate for cranial surgery for any reason.

    9. Subject has known HIV infection or known or suspected prion disease. 10. Subject has known allergies to drugs or excipients. 11. Subject is breastfeeding, pregnant, or expressed intent on becoming pregnant during the course of the study and Investigator feels pregnancy is a likely outcome during the study 12. In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive CNS disease that in the opinion of the Investigator would put the subject at risk as a participant in the study.

Sites / Locations

  • Mater Brisbane
  • RBWH
  • SVHM
  • The Alfred
  • The Austin
  • Hadassah Medical Center
  • Sheeba Medical Center
  • Tel Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-Label Safety

Arm Description

Participants roll-over from DA071976 or CLN100P.02

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2020
Last Updated
March 14, 2023
Sponsor
Cerebral Therapeutics LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04529954
Brief Title
Anti-Epilepsy Medication Valproate Administered Via ICV Route and Catheters and Pumps for CSF Infusion
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerebral Therapeutics LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Safety
Arm Type
Experimental
Arm Description
Participants roll-over from DA071976 or CLN100P.02
Intervention Type
Drug
Intervention Name(s)
Valproic Acid delivered to ICV
Intervention Description
Valproic Acid delivered to ICV via an implantable pump and catheter system
Primary Outcome Measure Information:
Title
Safety measured as drug or device related SAEs
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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. Exclusion Criteria: 1. Subject has any significant neurologic disease other than epilepsy. 2. Subject has had status epilepticus refractory to benzodiazepines and phenytoin in the past year 3. Subject is currently taking oral valproic acid or sodium divalproex. 4. Subject has known allergy to valproic acid, divalproex sodium, Epilim, or Depacon. 5. Subject has unstable depression or any major psychiatric disorder including psychosis, major depression, bipolar disorder that in the opinion of the Investigator would put the subject at risk as a participant in the study. 6. Subject has history or evidence of congestive heart failure, clinically significant peripheral edema, or anemia with a hematocrit <30%. 7. Subject has current diagnosis of cancer requiring treatment. 8. Subject in the opinion of the Investigator, is not a suitable candidate for cranial surgery for any reason. 9. Subject has known HIV infection or known or suspected prion disease. 10. Subject has known allergies to drugs or excipients. 11. Subject is breastfeeding, pregnant, or expressed intent on becoming pregnant during the course of the study and Investigator feels pregnancy is a likely outcome during the study 12. In the opinion of the investigator, the subject has a clinically significant or unstable medical condition (including alcohol and/or drug abuse) or a progressive CNS disease that in the opinion of the Investigator would put the subject at risk as a participant in the study.
Facility Information:
Facility Name
Mater Brisbane
City
Brisbane
State/Province
New South Wales
Country
Australia
Facility Name
RBWH
City
Brisbane
State/Province
New South Wales
Country
Australia
Facility Name
SVHM
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
The Austin
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Hadassah Medical Center
City
Jerusalem
Country
Israel
Facility Name
Sheeba Medical Center
City
Jerusalem
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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