NCT04153175

Brief Summary

This is a Phase 2 double-blind, randomized, placebo-controlled study to assess the safety and efficacy of ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC) in subjects with focal seizures, with temporal lobe onset with or without secondary generalization. Up to 70 subjects will be enrolled. Eligible subjects will be randomized in a 1:1 ratio to either CT-010 or placebo treatment. Up to 20 clinical centers will be enrolled.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2020

Typical duration for phase_2

Geographic Reach
2 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 6, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

August 21, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

3.5 years

First QC Date

November 3, 2019

Last Update Submit

March 11, 2024

Conditions

Refractory Epilepsy

Outcome Measures

Primary Outcomes (1)

  • 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

    84 days

Secondary Outcomes (5)

  • Seizure Severity Questionnaire (SSQ)

    84 days

  • QOLIE-10

    84 days

  • Patient Global Impression of Change (PGIC)

    84 days

  • BDI

    84 days

  • BAI

    84 days

Study Arms (2)

CT-010 Active Therapy

ACTIVE COMPARATOR

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.

Combination Product: ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC)

Placebo

PLACEBO COMPARATOR

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.

Combination Product: Placebo delivery via an implantable pump and a cranial port and dual lumen catheter (CIC)

Interventions

ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC)COMBINATION_PRODUCT

Subjects will be implanted with a drug delivery pump and catheters leading to the ICV space allowing delivery of CT-010.

CT-010 Active Therapy
Placebo delivery via an implantable pump and a cranial port and dual lumen catheter (CIC)COMBINATION_PRODUCT

Subjects will be implanted with a drug delivery pump and catheters leading to the ICV space allowing delivery of a placebo (saline).

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • For a subject to be eligible for this study, he or she must meet ALL of the following criteria:
  • Subject is male or female between the ages of 18 to 70 years old.
  • Subject is considered an appropriate surgical candidate by the implanting Neurosurgeon.
  • 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.
  • In the opinion of the Investigator, subject has disabling seizures.
  • 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)
  • 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.
  • 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)
  • 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.
  • 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 understands study procedures and has voluntarily provided signed, informed consent in accordance with institutional and local regulatory requirements.
  • Subject agrees to maintain the diary for the duration of the study alone or with the assistance of a competent individual.
  • 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.
  • Subject has any coagulopathy, ventricular anatomic distortion, or previous brain resection.
  • 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.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Mater Hospital Brisbane

Brisbane, New South Wales, Australia

Location

RBWH

Brisbane, New South Wales, Australia

Location

Royal Brisbane Medical Center

Brisbane, New South Wales, Australia

Location

The Mater

Brisbane, New South Wales, Australia

Location

SVHM

Melbourne, Victoria, Australia

Location

The Alfred

Melbourne, Victoria, Australia

Location

The Austin

Melbourne, Victoria, Australia

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2019

First Posted

November 6, 2019

Study Start

August 21, 2020

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(4)AU(7)