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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04153175




Registration number
NCT04153175
Ethics application status
Date submitted
3/11/2019
Date registered
6/11/2019

Titles & IDs
Public title
Study to Assess Intracerebroventricular (ICV) Delivery of CT-010 in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization
Scientific title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Assess Intracerebroventricular (ICV) Delivery of CT-010 Via an Implantable Pump and a Cranial Port and Double Lumen Catheter (ICVRX) in Subjects With Focal Seizures, With Temporal Lobe Onset With or Without Secondary Generalization
Secondary ID [1] 0 0
CLN100P.01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Refractory Epilepsy 0 0
Condition category
Condition code
Neurological 0 0 0 0
Epilepsy
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC)
Other interventions - Placebo delivery via an implantable pump and a cranial port and dual lumen catheter (CIC)

Active comparator: CT-010 Active Therapy - Subjects in the active comparator arm will have been randomized to receive active therapy through the implanted drug delivery system through the 3-month blinded period.

Placebo comparator: Placebo - Subjects in the placebo comparator arm will have been randomized to receive placebo therapy through the implanted drug delivery system for the 3-month blinded period.


Other interventions: ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC)
Subjects will be implanted with a drug delivery pump and catheters leading to the ICV space allowing delivery of CT-010.

Other interventions: Placebo delivery via an implantable pump and a cranial port and dual lumen catheter (CIC)
Subjects will be implanted with a drug delivery pump and catheters leading to the ICV space allowing delivery of a placebo (saline).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Median frequency of total monthly seizures during the Primary Evaluation Period as compared to the Baseline Period as well as a comparison of this Baseline Period/Primary Evaluation Period ratio for the active vs. placebo treatment groups
Timepoint [1] 0 0
84 days
Secondary outcome [1] 0 0
Seizure Severity Questionnaire (SSQ)
Timepoint [1] 0 0
84 days
Secondary outcome [2] 0 0
QOLIE-10
Timepoint [2] 0 0
84 days
Secondary outcome [3] 0 0
Patient Global Impression of Change (PGIC)
Timepoint [3] 0 0
84 days
Secondary outcome [4] 0 0
BDI
Timepoint [4] 0 0
84 days
Secondary outcome [5] 0 0
BAI
Timepoint [5] 0 0
84 days

Eligibility
Key inclusion criteria
Inclusion/
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-

For a subject to be eligible for this study, he or she must meet ALL of the following criteria:

1. Subject is male or female between the ages of 18 to 70 years old.
2. Subject is considered an appropriate surgical candidate by the implanting Neurosurgeon.
3. Subject has had confirmed refractory epilepsy for a minimum of 2 years, with unilateral or bilateral temporal lobe involvement with no more than 2 known extratemporal foci.
4. In the opinion of the Investigator, subject has disabling seizures.
5. Subject has had at least one seizure recorded by EEG or video EEG or invasive monitoring within the past 3 years consistent with focal temporal lobe seizures (a normal interictal EEG is consistent with focal seizures)
6. Subject has not achieved effective results previously from at least 3 AEDs in single or combination. An AED may be counted as failed medication if subject has been on it for at least 3-months and is still refractory.
7. Subject failed to obtain an adequate intake of oral valproate of at least 1,000 mgs a day and/or to achieve serum level of at least 60 µg/mL or in the opinion of the Investigator is not a candidate for oral valproate (including subject preference)
8. Per medical history, for the 3 months before informed consent an average of six or more disabling focal seizures of temporal lobe onset, with or without secondary generalization, per month.
9. Subject has seizures that are distinct, stereotypical events that can be reliably counted, in the opinion of the Investigator, by the subject or caregiver.
10. Subject understands study procedures and has voluntarily provided signed, informed consent in accordance with institutional and local regulatory requirements.
11. Subject agrees to maintain the diary for the duration of the study alone or with the assistance of a competent individual.

Subjects must NOT meet any of the following Exclusion criteria to be eligible for enrollment:

1. Subject has any neurologic or medical disease that is likely to progress over the course of the study and/or would interfere with the study.
2. Subject has any coagulopathy, ventricular anatomic distortion, or previous brain resection.
3. Subject has history, within 12 months prior to consent, of repetitive seizures that cannot be counted with confidence by the subject or competent adult/caregiver.
4. Subject has history of psychogenic nonepileptic seizures or seizures secondary to illicit drug or alcohol use, neoplasia, active central nervous system infection, demyelinating disease, degenerative neurological disease, progressive CNS disease or metabolic illness.
5. Subject has had status epilepticus refractory to benzodiazepines and a second agent within one year prior to consent
6. Subject is currently taking neuroleptic medication for behavior control.
7. Subject has a clear brain anatomic structural related lesion which distorts the normal anatomy or interferes with CSF fluid flow.
8. Subject has required (in addition to low dose stable use of benzodiazepines as part of antiepileptic regimen), in the 3 months prior to consent, benzodiazepine use more than 5 times per month for rescue seizure control. One use is defined as taking up to 3 doses in a 24-hour period.
9. Subject is currently implanted with an activated DBS, or RNS device used for treatment of a neurologic or psychiatric condition.
10. Subject currently has VNS and the VNS stimulation parameters are not stable. Stable shall be defined such that the stimulation parameters have not been changed in the last 3 months or the patient/designee is able to report "magnet swipe" during the same time period. The Investigator believes that the continued stable parameters can be maintained through the Primary Evaluation Period.
11. Subject has had more than 10 seizures in one day or more than 200 seizures in one month within last year.
12. Subject has known allergy to citrate, citric acid, valproic acid, divalproex sodium, any components of CT-010, or Depacon®.
13. Subject has unstable depression being treated with more than 1 antidepressant medication or has current evidence of or history within the past 2 years of DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, and has had a suicide attempt within the previous five years. Also excluded are subjects with a history of prolonged postictal psychosis or psychosis or depression secondary to a discontinued AED.
14. In the opinion of the Investigator, the subject has a clinically significant or unstable medical condition (e.g., uncontrolled diabetes or CHF) or a progressive CNS disease that would limit the subject's entry into the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
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
21/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2024
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Mater Hospital Brisbane - Brisbane
Recruitment hospital [2] 0 0
RBWH - Brisbane
Recruitment hospital [3] 0 0
Royal Brisbane Medical Center - Brisbane
Recruitment hospital [4] 0 0
The Mater - Brisbane
Recruitment hospital [5] 0 0
SVHM - Melbourne
Recruitment hospital [6] 0 0
The Alfred - Melbourne
Recruitment hospital [7] 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
Ramat Gan
Country [3] 0 0
Israel
State/province [3] 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/NCT04153175