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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04529954




Registration number
NCT04529954
Ethics application status
Date submitted
25/08/2020
Date registered
28/08/2020

Titles & IDs
Public title
Anti-Epilepsy Medication Valproate Administered Via ICV Route and Catheters and Pumps for CSF Infusion
Scientific 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
Secondary ID [1] 0 0
CLN100P.02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Valproic Acid delivered to ICV

Experimental: Open-Label Safety - Participants roll-over from DA071976 or CLN100P.02


Treatment: Drugs: Valproic Acid delivered to ICV
Valproic Acid delivered to ICV via an implantable pump and catheter system
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety measured as drug or device related SAEs
Timepoint [1] 0 0
2-years

Eligibility
Key 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 ß-human chorionic growth hormone (ß-HCG) pregnancy test result from a urine or blood sample collected per SOE.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2024
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Mater Brisbane - Brisbane
Recruitment hospital [2] 0 0
RBWH - Brisbane
Recruitment hospital [3] 0 0
SVHM - Melbourne
Recruitment hospital [4] 0 0
The Alfred - Melbourne
Recruitment hospital [5] 0 0
The Austin - Melbourne
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Israel
State/province [1] 0 0
Jerusalem
Country [2] 0 0
Israel
State/province [2] 0 0
Tel Aviv

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cerebral Therapeutics LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04529954